Regulatory Affairs

Responsibilities

• Author global pre‑market submissions, including 510(k) s and PMAs to the U.S. FDA in alignment with pre‑market and post‑market strategies.
• Create and manage IVDR Technical Files.
• Work with international colleagues on establishing design dossiers for their intended market for new product development and design changes.
• Advise business teams to consider the impact of current or emerging regulatory issues and collaborate with colleagues worldwide to ensure company practices align with the corporate regulatory risk posture.
• Ensure sound post‑market product regulatory strategies, including minimizing the risk of negative post‑market submissions needed for design changes, such as agency review delays.
• Function as the team expert for promotional material review, experimental design review, data analysis and product labeling as they relate to product registration and commercialization of IVD medical devices.

• Minimum Education:
  
  Bachelor’s Degree with 5+ years of experience in Life Sciences or a Master’s Degree with 3+ years of experience in Life Sciences, or a Doctorate with 0‑2 years of experience in Life Sciences.
• Subject matter expertise in registration and commercialization of medical devices.
• Previous experience as a 510(k) author is required; RAC certification is a plus.