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