Description
A global leader in lifesciences is seeking a Senior Regulatory Affairs specialist to join their growing team. The Senior Regulatory Affairs Specialist will be responsible for pre and most market regulatory functions globally.Responsibilities:
- Determines global regulatory pathways for various projects including type of regulatory submission or rationale required.
- Participates on project teams to define regulatory requirements of U.S. and international submissions, technical files
- Identifies guidance documents, international standards and consensus standards and assists teams with their interpretation.
- Prepares regulatory submissions to the FDA, the competent authorities and other regulatory authorities.
- Interacts with management, external agencies and companies
- Analyzes and makes recommendations regarding complaints received by the company and whether they are MDR or vigilance reportable; participates in complaint investigations and CAPA reviews as appropriate.
Requirements:
- Bachelor's Degree
- Experience with 510(K) submissions
- Understanding of complaints systems and MDR reportability
- 4+ Years Regulatory Affairs experience with medical devices or in-vitro diagnostics products