| Description/Comment: | • 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. 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, works with colleagues globally to facilitate and ensure company practices are consistent 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. 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. Subject matter expertise in registration and commercialization of medical devices. It would be a plus if you also possess previous experience in: 510k author. RAC certification |