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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.
- This firm promotes career growth and invests in their employees.
- This firm offers a collaborative, innovative and science-driven culture.
- 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.
Job Features
| Job Category | Regulatory Affairs |
| Reference Number | 201020 |
| Application Email | vritchie@shepherdrs.com |
Our client has a newly created opportunity for a Regulatory Affairs Senior Manager. In this highly influential role, you will be the primary Health Authority contact for all assigned projects.
Organization: Our client is among the global leading biotherapeutics organizations, with operations in 30+ countries and 20,000+ employees worldwide, they are committed to develop and deliver a wide range of lifesaving therapies to treat hemophilia and other primary immune deficiencies, and vaccines to avert influenza. They have applied their solutions in diverse areas such as cardiac surgery, organ transplantation, and burn treatment. The organization has an unrivalled passion and commitment to make a meaningful difference to people’s lives across the globe; now is an opportune time to join this team.
Responsibilities:
- Act as the main representative to regional health authorities for assigned products.
- Ensure all regulatory activities are consistent with the strategic course of the Global Regulatory Affairs Strategy Team.
- Provide regulatory guidance on regional, regulatory procedures and health authority requirements.
- Lead the preparation and contribution of briefing packages for allocated products.
- Support the GRL specialist while evaluating regulatory requirements to provide suitable regulatory advice.
- BS/MS, scientific background.
- 7 years of experience in the pharmaceutical industry, Biologics/Research & Development experience preferred.
- 3 -5 years of regulatory experience in a regulatory authority- facing role.
- Pharmaceutical/ Industry experience.
- Experience in negotiation and the resolution of issues with regulatory agencies with positive outcomes.
- Strategic and tactical thinking ability, combined with a “hands on” operational approach and business planning orientation.
- Team player that ensures all teams receive the support they need.
- Outstanding communication skills across all teams.
- Excellent problem solving ability.
Job Features
| Job Category | Regulatory Affairs |
| Reference Number | 201018 |
| Application Email | vritchie@shepherdrs.com |
Shepherd Regulatory Search has a newly created opportunity for a Senior Director Therapeutic Area Lead that will oversee a global team of GRLs and will be one of five decision makers on the R&D-wide TA leadership team.
In this integral role, you will be responsible for leading the development of global regulatory strategies for the TA.
Organization: Our client is among the global leading biotherapeutics organizations, with a presence in over 55+ countries, 18K+ employees and a rapidly growing pipeline. They have an unparalleled passion and commitment to save and improve lives across the globe, now is an exciting time to join this team.
Responsibilities:
- Provide scientific and regulatory vision and leadership in developing global regulatory strategies for this firm’s developmental portfolio.
- Work alongside key project management, clinical development and commercial development leads to ensure successful development of global regulatory strategies.
- Accountable for all clinical/ safety related submissions and communication with the FDA, EMA and other Regulatory Agencies.
- Participate in health authority meetings when needed.
- A minimum of 15 years’ experience in biotech or pharmaceutical industries with at least 10 years in Regulatory Affairs.
- 7 years’ experience (minimum) in leading and managing teams and promoting an engaging collaborative team environment.
- Solid background working in a complex and matrix setting required.
- Experience working in Regulatory Affairs across 2+ geographic areas (preferably the US and EU)
- A sound knowledge and understanding of pharmaceutical / biological product development and regulatory conditions for product development and approval in more than one key region (US, EU, Japan)
Job Features
| Job Category | Regulatory Affairs |
| Reference Number | 201007 |
| Application Email | vritchie@shepherdrs.com |
We have an exciting newly created opportunity for a Regional Regulatory Therapeutic Area Lead that will be the main point of regional contact and act as the subject matter expert for strategic leadership.
In this highly visible role, you will build teams and drive their performance.
Organization: Our client is an innovator and global leading biotherapeutics organization, with a presence in over 55+ countries, 18k+ employees and a rapidly growing pipeline. They are an organization with passionate dedication to save and improve lives across the globe, now is an exciting time to join this team.
Responsibilities:
- Provide insightful scientific and regulatory leadership and vision, in developing regional regulatory strategies for the developmental portfolio.
- Collaborate with key project management, clinical development and commercial development leads to ensure successful development and execution of regulatory strategies.
- Responsible for all clinical/ safety related submissions and interaction with the FDA, and Regulatory Agencies.
- Participate in health authority meetings when needed.
- A minimum of 10 years’ experience in pharmaceutical industries with at least 5 years in Regulatory Affairs.
- Experience in leading and managing teams and promoting an engaging collaborative team environment.
- Experience working in a complex and matrix setting required.
- Demonstrated knowledge of regional regulatory guidelines and legislative requirements.
- A comprehensive knowledge and understanding of pharmaceutical / biological product development and regulatory conditions for product development and approvals
Job Features
| Job Category | Regulatory Affairs |
| Reference Number | 201015 |
| Application Email | vritchie@shepherdrs.com |
We are excited to be recruiting for a leading 400-bed hospital; part of a leading 9-hospital-health system in Northern Michigan. They are looking for a proactive and passionate NICU Manager that will empower their nursing team to achieve the highest standard of clinical excellence.
This NICU Leader will develop and shape a first-class Neonatal Intensive Care Unit that will be the benchmark for high-quality patient care across northern Michigan.
Position Focus NICU Manager
- Supervise 30+ employees, including RNs, nursing clerks and nursing techs
- Oversee, evaluate, and promote desired patient outcomes that meet patient/family needs.
- Evaluate the effectiveness of nursing practices and identify opportunities to improve care delivery.
- The NICU Manager reports to the System Executive Director.
- This hospital is in the process of constructing a new building for their Level III NICU.
- Live in a beautiful location that offers great access to beaches, outstanding outdoor recreation, arts, wineries, and festivals.
- BSN required; MSN preferred.
- Level III NICU experience highly desired.
- A minimum of 2- years nursing experience within an acute care hospital required
Job Features
| Job Category | Construction & Architecture |
| Reference Number | 4510DG |
| Salary | 90,000 - 120,000 |
| Application Email | charuaqusag@gmail.com |
We are excited to be recruiting for a leading 400-bed hospital; part of a leading 9-hospital-health system in Northern Michigan. They are looking for a proactive and passionate NICU Manager that will empower their nursing team to achieve the highest standard of clinical excellence.
This NICU Leader will develop and shape a first-class Neonatal Intensive Care Unit that will be the benchmark for high-quality patient care across northern Michigan.
Position Focus NICU Manager
- Supervise 30+ employees, including RNs, nursing clerks and nursing techs
- Oversee, evaluate, and promote desired patient outcomes that meet patient/family needs.
- Evaluate the effectiveness of nursing practices and identify opportunities to improve care delivery.
- The NICU Manager reports to the System Executive Director.
- This hospital is in the process of constructing a new building for their Level III NICU.
- Live in a beautiful location that offers great access to beaches, outstanding outdoor recreation, arts, wineries, and festivals.
- BSN required; MSN preferred.
- Level III NICU experience highly desired.
- A minimum of 2- years nursing experience within an acute care hospital required
Job Features
| Job Category | Non Profit |
| Reference Number | 4525JP |
| Salary | 150,000 - 170,000 |
| Application Email | charu@aqusagtechnologies.com |