Principal Regulatory Affairs

Job Summary

Responsible for developing regulatory strategies for global approvals, the full-time remote Principal Regulatory Affairs will manage product submissions, negotiate with regulatory authorities, and lead projects impacting product development.

Key responsibilities

• Determine requirements for product submissions and regulatory filings for national or multi-national launches while monitoring regulatory changes
• Communicate regulatory requirements and recommend strategies to internal and external stakeholders, ensuring alignment with business objectives
• Lead complex projects involving regulatory pathways, manage timelines, and oversee internal and external audits to ensure compliance

Required qualifications

• B.A. or B.S. degree in a life science field, engineering, medical technology, regulatory science, or a related discipline
• 5+ years of diverse regulatory experience in the medical device industry, including pre- and post-market activities and independent submissions
• Extensive experience with regulatory submissions such as 510(k)s and CE Technical Files
• Strong background in negotiating with regulatory agencies, including the FDA and notified bodies