Regulatory Affairs Specialist - Medical Device

Title: Staff Regulatory Affairs

Location: REMOTE

Duration: 12 Months

MUST HAVE : RAC certification.

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• 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.
• It would be a plus if you also possess previous experience in: 510k author.
• In this role, you will have the opportunity to: 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.
• Advise business teams to consider the impact of current or emerging regulatory issues, works with colleagues globally to facilitate and ensure company practices are consistent with the corporate regulatory risk posture.
• Create and manage IVDR Technical Files.
• The essential requirements of the job include: 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 Doctorate with 0-2 years of experience in Life Sciences.
• Work with international colleagues on establishing design dossiers for their intended market for new product development and design changes.
• Subject matter expertise in registration and commercialization of medical devices.
• 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.