Health Specialist Jobs

About The Position

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.