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Regulatory Affairs Staff Specialist
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Full-time
- This includes preparing and submitting regulatory submissions, such as 510(k) premarket clearances, De Novo Classifications and Premarket Approval (PMA) applications, and ensuring they contain accurate and complete information.
- The specialist acts as a liaison between the Market Access Team and the FDA. They engage in correspondence, meetings, and interactions with the FDA to address regulatory inquiries, respond to requests for additional information, and seek clarification on regulatory matters under the guidance of the Director, US Market Access.
- Participate in multidisciplinary project teams within the US Market Access Department providing guidance and direction on current regulatory pathways and expectations.
- Work closely with quality assurance and quality control teams to establish and maintain appropriate quality systems for IVDs. This includes ensuring compliance with Good Manufacturing Practices (GMP) and Quality System Regulations (QSR).
- Work with document control group to ensure regulatory document archiving.
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