Senior Regulatory Affairs Specialist

LifeNet Health • Virginia Beach, VA

37d • $87,226 - $145,377

About The Position

The Senior Regulatory Affairs Specialist supports LifeNet Health’s global regulatory strategy and compliance across the medical device, biologics, tissue, and combination product industries. The role develops regulatory strategies for new product development teams; plans and prepares product dossiers for regulatory approval in the United States and internationally; evaluates the regulatory impact of post-approval design and manufacturing changes and develops submission plans to support business and registration continuity; and works with commercial teams on appropriate marketing claims.

Requirements

• At least 5 years of regulatory experience in the medical device industry or a similar regulated industry.
• At least 2 years of experience with high-risk regulated products, such as Class III/PMA products, in the United States, European Union, and other geographies.
• An agile learning mindset and ability to find creative solutions to complex problems.
• Analytical curiosity about existing technical workflows and an active interest in finding compliant, innovative ways to improve them.

Nice To Haves

• Master’s degree.
• At least 2 years of experience with collagen or animal-derived medical devices.

Responsibilities

• Develop regulatory strategies for new product development teams.
• Plan and prepare product dossiers for regulatory approval in the United States and international markets.
• Evaluate the regulatory impact of post-approval design and manufacturing changes.
• Develop submission plans that support business and registration continuity.
• Support development and negotiation of appropriate marketing claims with commercial teams.
• Support the organization’s global regulatory strategy and compliance.

Benefits

• Best-in-class benefits; specific benefit types are not listed.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed