Job Archives

Full Time
CA
Posted 8 months ago
Elevate the Arts with Your Fundraising Flair! Are you a master of forging connections, a fundraising virtuoso, and a relationship maestro all in one? Do you have a passion for the performing arts that's as boundless as your enthusiasm for building partnerships? If so, we've got the perfect stage for you to shine on! About Us: We are a dynamic and vibrant cultural institution that thrives on creativity and community engagement. Our stage has witnessed breathtaking performances that touch hearts and minds alike, and now we're searching for a Director of Development to help us take our mission to the next level. The Role: As the Director of Development, you're not just a fundraiser; you're an artistic collaborator, a strategic thinker, and a relationship nurturer. Your role is a hybrid masterpiece, blending the worlds of major gifts, board presentations, and communication enhancement. Key Responsibilities: 1. Crafting Symphony of Major Gifts: You're the lead conductor of our major gifts orchestra. Your knack for cultivating and stewarding relationships will ensure that our patrons and supporters find joy in supporting the arts. You'll compose personalized strategies to engage donors, creating harmonious partnerships that resonate with their passions and aspirations. 2. Dazzling Board Presentations: Your pitch-perfect presentation skills will have the board members on their feet! You'll craft compelling narratives that showcase our accomplishments, vision, and funding needs. With your finesse, board meetings will become captivating performances that inspire confidence and generosity. 3. Bridging Board-Administration Divide: As the liaison between our visionary board and our dedicated administration, you'll be the bridge that ensures seamless communication. Your gift for understanding the nuances of both sides will harmonize their efforts, resulting in a more cohesive and impactful organization. 4. Symphony of Relationship Building: Your relationships are the sweet notes that keep our organization in tune. You'll nurture existing partnerships while orchestrating the growth of new ones, from individual donors to corporate supporters. Your charm and charisma will be the backbone of our fundraising success. 5. Ovation-Worthy Strategy: You'll shape and execute a fundraising strategy that aligns with our artistic goals. Your strategic insights and data-driven decisions will be the sheet music guiding us towards sustained financial growth. Qualifications:
  • A proven track record in major gift fundraising, with a background in nurturing donor relationships that harmonize with the organization's mission.
  • A virtuoso in public speaking, with the ability to captivate and inspire both the board and external partners.
  • A diplomat who excels at communication, capable of fostering unity and collaboration between different wings of our organization.
  • Passionate about the arts and eager to contribute to a thriving creative community.
  • A strategic thinker who can compose compelling fundraising strategies that resonate with donors.
Perks and Applause:
  • An opportunity to play a lead role in elevating the arts and contributing to a vibrant cultural landscape.
  • Collaborate with passionate colleagues who share your love for creativity and community.
  • Be part of a dynamic, supportive, and innovative environment that encourages fresh ideas and initiatives.
  • Competitive compensation package that recognizes the value of your skills and contributions.
Join Our Symphony of Success: If you're ready to make music with your fundraising finesse, bridge the gap between visionaries and administrators, and champion the arts in a unique and impactful way, we can't wait to hear your melody. Step into the spotlight and apply today – let's create a masterpiece together!   Contact: Donald Ross dr@merraine.com

Job Features

Job CategoryGeneral Opportunities

Elevate the Arts with Your Fundraising Flair! Are you a master of forging connections, a fundraising virtuoso, and a relationship maestro all in one? Do you have a passion for the performing arts that...

Full Time, PERMANENT
WI
Posted 2 years ago
Our client is a leader in manufacturing technology on an aggressive growth path and looking to add talent to their financial team. They boast state of the art software and equipment to best meet their customers needs and have an excellent culture along with benefits that include hybrid work from home. unlimited vacation, etc. Looking for a superstar who is ready to grow into a CFO in the near future. This position will lead a team and be responsible for directing financial planning and budgeting. Will lead the company's forecasting, financial reporting, costing and financial statement processes. Must be strategic minded and be able to lead a team. The qualified candidate will have a degree in accounting and finance and 8+ years in manufacturing accounting and leadership in a manufacturing company. Must have a strong hands on knowledge of operational costing and analysis. A CPA is preferred but no required. Salary: 120K-140K plus bonus   Contact: Laurie Boyle - laurie@shepherdsg.com

Job Features

Job CategoryFinance/Accounting and HR recruiting

Our client is a leader in manufacturing technology on an aggressive growth path and looking to add talent to their financial team. They boast state of the art software and equipment to best meet their...

Full Time
Chicago, IL
Posted 2 years ago
This is an opportunity to come in as an Executive Vice President at a global company that focuses on commercial restoration services. The industries they work with include insurance, industrial & manufacturing, data centers, renewable energy, marine & offshore, healthcare, and education. They have the most experienced technical restoration specialists in the industry on their team. As Executive VP one will act as a strategic partner, leader, and visionary for the global team. Working directly with the President to lead business growth and continue to build upon the organization’s One Company/One Team approach. Interacting with internal and external stakeholders with everyone’s best interest in mind and maintain best practices to best serve customers worldwide. Compensation for this role will be quite competitive and includes strong bonus potential. The organization embraces a very collaborative work environment. In 2021 they have been recognized as one of the Great Places to Work and they made Inc. 5000’s list of Fastest Growing Companies. Other perks include the ability to have global responsibility, make business decisions, make an impact on careers for other people within the organization, and the opportunity to be part of and engage with others in the senior leadership team.   Responsibilities include:
  • Managing the sales and operations for the organization’s contamination consulting, preservation, technical reconditioning, and maintenance services worldwide. Primary clients include commercial property adjusters, facility restoration companies, risk managers, and brokers; as well as energy and marine markets.
  • Assure delivery of superior work quality and customer service, retention and expansion of business
  • Maintain a motivated, engaged, and effective workforce across markets
  • Work with leadership of the organization to define the vision, develop, and implement strategic and innovative tactics to grow the organization’s profitability and determine investments to achieve company objectives
  • Partner to develop a sales philosophy and market strategy for each market segment and geography, while making optimum use of the resources across the organization’s broad platform
  • Expand organizational capability and cost out optimization to meet and exceed profit plan targets
  • Drive ownership and collaboration across all stakeholder groups that align to customer expectations and drive profit plan objectives
  • Promote talent acquisition and development activities for the global team
  • Support diversity and inclusion initiatives to ensure a diverse workplace that mirrors the company’s global customers and communities.
  • Communicate with marketing leadership to create and implement an effective relationship and branding strategy with emphasis on thought leadership
  • Work with finance and accounting team to monitor divisional cash flow
  • Embrace innovation, process improvement, and professional development
  • Manage PNL for the organization in North America and globally
  • Keen focus on maximizing return on investment
  Qualifications include:
  • At least 10 years of leadership experience within a global organization
  • Experience in technical restoration, forensic consulting, insurance, or related industries
  • Ability to recognize and capitalize on opportunities
  • Ability to identify threats and mitigate or prevent them from materializing
  • Must encompass a strong understanding of the company’s services and demonstrate a range of strategic sales skills
  • Strong financial literacy and business acumen with the ability to apply to department implications and solutions.
  • Time management, strategic thinking, prioritization, and organizational skills
  • Ability to translate business and organizational challenges into concrete department goals and objectives
  • Successful sales and marketing directly to insurance companies
  • Willingness to travel on average of 30% to 50% of the workweek for meetings, as well as attending other work-related activities that may be outside of normal business hours
  • International experience, including having worked with teams in the Nordic Region
  • Ability to bring teams together

Job Features

Job CategoryGeneral Opportunities

This is an opportunity to come in as an Executive Vice President at a global company that focuses on commercial restoration services. The industries they work with include insurance, industrial & ...

PERMANENT
New York (NY)
Posted 4 years ago
POSITION SUMMARY: Assists residential management in scheduling direct support positions across all residences optimizing staffing to minimize overtime. Works closely with program management to schedule staff and cover call outs and PTO coverage, within staffing guidelines and budget. Works with management to develop a consistent scheduling system across all programs. Ensures schedules for all homes are current and accurate. Responsible for creating and maintaining a position control system, ensuring each residence/community does not exceed its budgeted FTEs. Performs payroll functions of editing and approving timecards for per diem staff. Provides oversight for all per diem staff and ensures they are current in required training. Demonstrates excellent attendance & good employee/customer relations. Maintains a calm professional demeanor at all times.   Knowledge/Skills/Abilities:
  • Ability to work accurately with strong attention to detail
  • Computer proficiency with Microsoft Office, including Excel, and Payroll systems
  • Ability to understand staffing minimums and financial information to minimize overtime
  • Excellent interpersonal skills
  • Strong oral and written communication skills
  • Ability to plan, organize and prioritize work activities
  • Ability to adapt to changes in work environment and manage competing demands
  POSITION QUALIFICATIONS: Minimum Education:
  • Bachelor's in Business, Human Services or related field preferred, high school graduate or equivalent required.
Minimum Experience:
  • Proven experience in a similar role maximizing scheduling to reduce overtime. High proficiency in Microsoft Word and Excel required. Experience with time and attendance system, particularly Kronos, preferred

Job Features

Job CategoryGeneral Opportunities

POSITION SUMMARY: Assists residential management in scheduling direct support positions across all residences optimizing staffing to minimize overtime. Works closely with program management to schedul...

Full Time
WA
Posted 4 years ago
We have an exciting opportunity for a Medical Liaison-Oncology to join a small company within a global pharmaceutical company that is driven by scientific innovation that touches patients' lives worldwide.   Organizational Attributes:
  • Join a global company with a culture that values collaboration, diversity, scientific ingenuity, curiosity, discovery, and breakthrough innovation.
  • They provide fantastic opportunities to grow, develop new skills and, and share your best ideas in a fast-moving and engaging environment.
  • They are among Fortune Magazine’s most admired companies.
  • They are voted as an employee of choice by publications outside the industry.
  Position Focus:
  • Builds long-term professional relationships and advocacy; and secures contributions from Decision-makers, Medical Experts, and Health Care Professionals.
  • Identifies potential research opportunities that align with medical and business strategies including preclinical and translational research and epidemiology projects.
  • Educates Health Care Professionals, Regulatory Agencies, and Federal stakeholders on trending data and pipeline platforms.
  • Offers medical support as a part of a cross-functional team to clinical trials.
  Requirements
  • PharmD, PhD, or MD or a doctoral degree required.
  • 2 years oncology postdoctoral liaison experience.
  • Knowledge of oncology clinical medicine, medical research, disease management in at least one therapeutic discipline.
  • Knowledge of oncology clinical medicine, disease management and medical research in at least one therapeutic area.
  Contact: Shelly Wool

Job Features

Job CategoryPharmaceutical
Reference Number3-5-20SW
SalaryCompetitive

We have an exciting opportunity for a Medical Liaison-Oncology to join a small company within a global pharmaceutical company that is driven by scientific innovation that touches patients’ lives...

Full Time
Florida (FL)
Posted 4 years ago
Located in one of the most desirable communities in Florida is an iconic global leading pharmaceutical company that develops and distributes orthopedic solutions across the globe.   We are searching for a Clinical Research Associate with solid experience in the medical device field; orthopedic experience will be an advantage.   The company provides relocation assistance and offers remote working opportunities for qualified candidates.   Why join this organization: This Leading Medical Device Company is privately owned, boasts impressive double digit year over year growth, and has a vision to establish itself in the public space and grow to become a $1Billion Company!   Outstanding location!
  • Live and work in a community in Florida consistently rated as one of the nation’s most livable cities offering
  • Reasonably priced and high-quality housing
  • No state income tax
  • Outstanding schools, and nationally recognized healthcare facilities.
  Position Focus:
  • Monitor clinical studies and ensure they are recorded and reported and meet SOPs, and applicable regulatory requirements.
  • Help investigative sites with acquiring and maintaining IRB and EC approval.
  • Request any updated site-related essential and non-essential documentation assess for content and ensure it complies with regulatory requirements.
  • Ensure investigative sites report adverse happenings consistent with protocol specifications.
  CRA Requirements:
  • Associate and / or Bachelor’s degree required.
  • A minimum of 1 year clinical research experience in regulated medical device.
  • Post market experience.
  • Strong understanding of Good Clinical Practice (GCP).
  • Experience in orthopedics desirable.
  • CCRA or CCRP certification preferred.
  • Experience with electronic data capture (EDC) technology an advantage.
  Contact: Kelly Gutradt

Job Features

Job CategoryPharmaceutical
Reference NumberFEB19KG

Located in one of the most desirable communities in Florida is an iconic global leading pharmaceutical company that develops and distributes orthopedic solutions across the globe.   We are search...

Full Time
MA
Posted 4 years ago
We are searching for a Medical Science Liaison Oncology to join an industry-renowned pharmaceutical business with a strong Oncology pipeline. They have a passionate dedication to developing innovative therapeutic solutions that make a meaningful difference in people's lives and healthcare worldwide.   Awesome potential for career advancement and professional development!
  • Organization: Explore an opportunity to join a forward-thinking pharmaceutical company that combines breakthrough research and innovation while staying true to their values of integrity, quality, teamwork, and trust.
  • Culture: provides a collaborative work environment that empowers and enables their employees.
  Position Focus Medical Science Liaison (Oncology)
  • Develop and cultivate professional relationships with well-established healthcare providers and principal decision makers.
  • Deliver presentations on healthcare economics, outcomes research data, and medical/clinical as it relates to company products to healthcare professionals, Medicaid decision-makers, and others.
  • Coach and mentor new hires and less experienced Medical Science Liaisons and oversee special projects when necessary.
  • Provide a channel for communication between organizational research and the medical community concerning ideas for future research with the company’s products.
  Requirements Medical Science Liaison (Oncology)
  • Advanced degree in medical biosciences (M.D., PhD, PharmD).
  • A minimum of 3 years MSL experience in oncology.
  • Must have a strong and broad-based scientific and pharmaceutical background and excellent presentation skills.
  • Understand the pharmaceutical business environment combined with knowledge of its commercial operations such as sales and marketing
  Contact: Shelly Wool

Job Features

Job CategoryRegulatory Affairs
Reference NumberFEB19

We are searching for a Medical Science Liaison Oncology to join an industry-renowned pharmaceutical business with a strong Oncology pipeline. They have a passionate dedication to developing innovative...

PERMANENT
New Jersey
Posted 4 years ago
We are excited to be recruiting for a global pharmaceutical company in their search for a Manager, Pricing Analytics and Reporting. Join a company that combines far-reaching and innovative therapeutic solutions that are helping to shape positive and meaningful change! Awesome potential for career advancement and professional development!   Organization: Explore an opportunity to join a forward-thinking pharmaceutical company that combines breakthrough research and innovation while staying true to their values of integrity, quality, teamwork, and trust. Culture: provides a collaborative work environment that empowers and enables their employees.   Position Focus:
  • Develop analytical tools to gauge the influence of current and new US Federal and State Price Transparency laws with regard to the in-line portfolio and the late stage pipeline.
  • Collaborate with Legal, Compliance, Brands and other stakeholders across all critical areas to infer the law in relation to price action calculations.
  • Work alongside the Director of Pricing to determine key analytics that affect pricing strategy.
  • Pinpoint any at-risk activities and their projected impact on the organizations ability adhere to US Federal and State Price Transparency Policies.
  Requirements:
  • A minimum of 5 years’ experience in the pharma/biotech industry; including 2+ years of pricing specific experience.
  • Pricing and/or Market Access background, with experience developing pricing models and working on state legislation for transparency reporting.
  • Knowledgeable re: Wholesale Acquisition Cost (WAC) pricing.
  • Bachelor’s degree required; Master’s degree preferred.
  Contact: Kelly Gutradt

Job Features

Job CategoryPharmaceutical
Reference NumberFEB4C
Salary$120,000 - $140,000 plus bonus

We are excited to be recruiting for a global pharmaceutical company in their search for a Manager, Pricing Analytics and Reporting. Join a company that combines far-reaching and innovative therapeutic...

PERMANENT
New Jersey
Posted 4 years ago
We have a terrific opportunity for a Senior Manager, Medical Writing-Neurology/CNS, with expertise in regulatory writing, to join a global pharmaceutical company leading drug development in neuroscience by combining state-of-the-art research with treatment solutions that create a positive and meaningful impact.   Awesome potential for career advancement and professional development! Organization: Explore an opportunity to join a forward-thinking pharmaceutical company that combines breakthrough research and innovation while staying true to their values of integrity, quality, teamwork, and trust. Culture: provides a collaborative work environment that empowers and enables their employees. Position Focus:
  • Develop PCS, protocols, and protocol amendments, often functioning as the compound lead. Lead and contribute to the writing of marketing application submission documents.
  • Provide direction to other medical writing on how to apply industry and medical writing best practices.
  • Contribute to process improvement across functional areas.
  • Collaborate with teams to form project specific metrics that adhere with standard project metrics.
Requirements:
  • Bachelor’s degree in Life Sciences, English, or other related discipline; advanced degree preferred.
  • 5+ years of medical writing experience with specialization in the regulatory space including writing for submissions, IBs, NDAs, Module 2 summaries, etc.
  • Therapeutic experience in Neuroscience/CNS; with experience in epilepsy, movement disorders, and neurodegenerative diseases a plus.
  • Certification in Medical Writing/Regulatory Writing (RAC) desirable.
  Contact: Kelly Gutradt

Job Features

Job CategoryPharmaceutical
Reference NumberFEB4B
Salary$120,000 -$140,000 plus bonus

We have a terrific opportunity for a Senior Manager, Medical Writing-Neurology/CNS, with expertise in regulatory writing, to join a global pharmaceutical company leading drug development in neuroscien...

PERMANENT
New Jersey
Posted 4 years ago
Our client, a global pharmaceutical leader with a VERY robust oncology pipeline, is seeking a Director, Market Access Strategy, to manage the development and implementation of responsibility for Market Access Operations for 12+ distinctive indications, and 8+ different tumor types. We are looking for a cross-functional leader with extensive experience in Market Access and Organized Customer Strategy to lead Oncology Market Access and be an integral part of collaborative efforts organization-wide.   Awesome potential for career advancement and professional development! Organization: Explore an opportunity to join a forward-thinking pharmaceutical company that combines breakthrough research and innovation while staying true to their values of integrity, quality, teamwork, and trust. Culture: provides a collaborative work environment that empowers and enables their employees.   Position Focus:
  • Support market access strategy in Oncology through collaborating across all of market access including pricing, payer, reimbursement, and supplier relations.
  • The main liaison with the organization’s alliance partner’s market access to develop launch plans on new indications, and market access resources.
  • Oversee approval process for resources for the payer team and develop approaches for aligned and new products to ensure commercial success of the portfolio.
  • Will really be responsible for determining market access strategy and leading work teams; developing ideas for pull through across various channels; will navigate IDNs, specialty pharma, large oncology clinics, etc.; and develop messaging and tools for field teams.
  • Work alongside legal, compliance, and regulatory to understand existing and new interface / interaction with customers.
  • Will engage with stakeholders including C-Suite executives, payers, physicians, specialty pharmacy, KOLs, PBMs, and policy and pathway development.
  Requirements:
  • 10+ years’ experience in the pharmaceutical industry with progressive responsibility and/ or diverse experience.
  • Strong expertise in Market Access Strategy paired with Account Management experience.
  • Knowledge of the competitive healthcare landscape and the payer customer’s decision cycle, with insight of how this affects decisions as well as the ability to transfer this knowledge into actionable insights in order to formulate strategies.
  • Experience developing valid metrics, gathering information, and pinpointing potential opportunities to enhance new product planning, and strategy evolution.
  • Bachelor’s degree in life sciences or business; advanced degree preferred.
  Contact: Kelly Gutradt

Job Features

Job CategoryPharmaceutical
Reference NumberFEB4A
SalaryCompetitive compensation package includes generous base salary, bonus, LTI

Our client, a global pharmaceutical leader with a VERY robust oncology pipeline, is seeking a Director, Market Access Strategy, to manage the development and implementation of responsibility for Marke...

Full Time, PERMANENT
MA
Posted 5 years ago
We have an exciting opportunity for a Laser Systems Engineer to join a company in New England providing cutting-edge biotherapeutics technologies for a variety of industries.   As the Laser Systems Engineer, you will be an innovator with a passion to go beyond the boundaries of convention; join a talented team of a rapidly growing company with an ambitious entrepreneurial vision.   Position Focus Laser Systems Engineer
  • Design, Development and Manufacture of laser modules and associated electronics for OEM applications.
  • Provide oversight of the creation and manufacturing of test and assembly fixtures and software.
  • Provide oversight of the final documentation for new product releases into manufacturing including ECO’s, data sheets, and a bill of materials.
  Why join this company
  • Join a rapidly growing company that develops state-of-the-art analytical technologies for a variety of industries including R&D and life science industries.
  • Play an integral role in a company where you can have an immediate impact within a fast-moving and exciting environment that promotes continuous learning.
  Requirements Laser Systems Engineer
  • An advanced degree in physics, optics, photonics, mechanical engineering, or scientific discipline required.
  • 10+ years’ experience designing, developing, and testing semiconductor-based laser modules.
  • Knowledge of semiconductor lasers and electro-optic packaging of semiconductor lasers.
  • Experience with quantum cascade lasers or external cavity lasers strongly preferred.
  • Extensive experience with tunable external cavity solid state laser systems
  Contact: Mira Djelic

Job Features

Job CategoryOptics
Reference Number1118MD
Application Emailmira@shepherdsg.com

We have an exciting opportunity for a Laser Systems Engineer to join a company in New England providing cutting-edge biotherapeutics technologies for a variety of industries.   As the Laser Syste...

Full Time, PERMANENT
New York (NY)
Posted 5 years ago
Shepherd Optics Search has an exciting opportunity to join an established leader in the Silicon Photoncs and III-V Semiconductor based integrated circuits industry producing breakthrough solutions that boost performance and cost efficiency. They are seeking an analytical Semiconductor Laser Design Engineer that enjoys working autonomously with a strong passion for learning that loves collaborating to join a progressive firm creating next generation technology   Position Focus Semiconductor Design Engineer
  • Develop III-V semiconductor based opto-electronic technology
  • Develop models to replicate the performance of III-V lasers and integrated circuits
  • Develop device characterization setup
  • Define verification tests in order to characterize different aspects of device performance.
  Requirements Semiconductor Design Engineer
  • PhD with min. 3+ years experience designing and modeling semiconductor lasers.
  • Experience with data analysis and simulation tools such as Python or MATLAB etc..
  • Experience developing and operating electo-optic test station to define photonic integrated circuits.
  • Familiarity with DOE methodology.
  Contact: Mira Djelic

Job Features

Job CategoryOptics
Reference Number1114MD
Application Emailmira@shepherdsg.com

Shepherd Optics Search has an exciting opportunity to join an established leader in the Silicon Photoncs and III-V Semiconductor based integrated circuits industry producing breakthrough solutions tha...

Full Time, PERMANENT
Northwest
Posted 5 years ago
Shepherd Optical Search is excited to be recruiting on behalf of a company with an established reputation as an industry innovator and leader. They are searching for an R&D Optical/Fiber Optics Scientist/Engineer to join a firm that promotes collaboration and the sharing of great ideas throughout their enterprise. This scientist/engineer will work on a multitude of applications including and not limited to communications, datacom, biomedical instrumentation, astronomy, digital projection, industrial laser, medical, spectroscopy, 1D & 2D arrays, and sensors. Position Focus Senior Optical / Fiber Optics Engineer Northwest
  • Has hands-on responsibility for developing new products.
  • Interface with clients to determine their requirements.
  • Work alongside a small engineering team to identify the root causes of interdisciplinary issue and provide innovative solutions.
  • Document and record test methodology, component specifications, optical design, and modification.
 Requirements:
  • Masters in Optics, Fiber optics or associated discipline; PhD preferred.
  • A minimum of 5 years broad based technical expertise.
  • Experience in statistical quality / reliability is a plus.
  Contact: Mira Djelic

Job Features

Job CategoryOptics
Reference Number1117MD
Application Emailmira@shepherdsg.com

Shepherd Optical Search is excited to be recruiting on behalf of a company with an established reputation as an industry innovator and leader. They are searching for an R&D Optical/Fiber Optics Sc...

Full Time, PERMANENT
CA
Posted 5 years ago
Our client is a global company offering a wide variety of cable solution offerings seeks a Senior Optical/Module Assembly Process Development Engineer to support the production of high-speed optical transceivers for optical computer interconnects. Position Focus Senior Manufacturing Process Development Engineer
  • Support both domestic and global production operations and facilities.
  • Oversee process development, improvements such as planning, and the implementation of DOEs.
  • Investigate and fix root cause of line excursions in relation to process, and / or components.
  • Schedule and perform equipment preventative maintenance.
Requirements Senior Manufacturing Process Development Engineer
  • 5+ years’ experience in high-speed optoelectronic or similar experience.
  • Relevant engineering degree.
  • Demonstrated hands on experience supporting processes, tooling and materials used in the industry.
  • Team-focused orientation and will have the ability to develop and maintain relationships with internal and external entities.

Job Features

Job CategoryOptics
Reference Number1113MD
Application Emailmira@shepherdsg.com

Our client is a global company offering a wide variety of cable solution offerings seeks a Senior Optical/Module Assembly Process Development Engineer to support the production of high-speed optical...

Full Time, PERMANENT
TX
Posted 5 years ago
Our client is a Global Medical Device company that is an established leader and innovator with multiple approved products. They partnered with us to find a Senior Regulatory Affairs Specialist to prepare regulatory filings to allow for my client’s products to be marketed globally. This position will participate in development of regulatory strategies to gain approval of new products, new intended uses for existing products, and existing products in new regions and changes to existing products   Responsibilities:
  • Prepares submissions and compiles documentation in support of domestic and international product marketing approvals. Regulatory submissions may be related to new products, new intended uses for existing products, and introduction of existing products into new geographies.
  • Works with the franchise and sustaining engineering teams to establish global regulatory strategies and plans needed to obtain the appropriate regulatory clearances/approvals for new and existing products.
  • Reviews proposed modifications to intended use, design, labeling, materials, and manufacturing processes to assess impacts existing regulatory approvals/clearances. Works with teams to develop strategies and plans to manage the implementation of changes.
  • Assists design and development teams in developing and documenting appropriate design controls needed to support planned global regulatory submissions
  • Reviews Engineering Change Plans and provide input outlining impacts to existing and in-process regulatory approvals/clearances.
  • Maintains open communications with local country representatives, including distributors, and local regulatory agencies as required.
  • Read and understand global regulations and provide regulatory advice, as required.
  • Reviews product labeling to assure compliance with regulations.
  Organization
  • This firm promotes career growth and invests in their employees.
  • This firm offers a collaborative, innovative and science-driven culture.
  Requirements:
  • Bachelor’s degree in life science to include Life Sciences, Engineering Sciences, or similar disciplines or equivalent experience.
  • At least 5-7 years of experience working in a regulated environment, such as medical devices.
  • Experience compiling and submitting 510(k)s.
  • At least 3-5 years Regulatory Affairs experience working in pharmaceuticals or medical devices.
  • Strong familiarity with global medical device regulations and standards
  • Experience compiling and submitting technical documentation.
  • Proficiency with Microsoft Office business software.
  • Ability to implement or create databases and produce documents and presentations.
  Contact: Ed Canning

Job Features

Job CategoryRegulatory Affairs
Reference Number201020
Application Emailvritchie@shepherdrs.com

Our client is a Global Medical Device company that is an established leader and innovator with multiple approved products. They partnered with us to find a Senior Regulatory Affairs Specialist to prep...