Senior Manager, Regulatory Affairs
New
Based in United StatesFull-TimeManager
Salary$161,920 - $202,400
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Job Details
- Experience
- 8–10+ years
- Required Skills
- Risk Management
Requirements
- Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, or a related discipline (advanced degree preferred).
- 8–10+ years of progressive regulatory affairs experience within the medical device industry.
- Proven experience leading FDA Class I and II submissions, including 510(k) processes.
- Experience with EU MDR (2017/745) technical documentation, conformity assessments, and global regulatory frameworks.
- Direct experience engaging with the FDA and EU Notified Bodies.
- Strong knowledge of FDA regulations including 21 CFR 820/QMSR, 21 CFR 807, 803, and 806.
- Deep understanding of ISO 13485, ISO 14971, quality systems, and risk management.
- Experience supporting FDA inspections, audits, and regulatory compliance activities.
- Strong regulatory writing, documentation oversight, and submission planning skills.
- Excellent leadership, mentoring, negotiation, and stakeholder management abilities.
- Willingness to travel periodically (approximately 20%) for audits and regulatory meetings.
- RAC certification or equivalent is a plus.
Responsibilities
- Develop and execute comprehensive global regulatory strategies aligned with business goals and product roadmaps.
- Lead regulatory pathways for U.S., EU, and international markets, including FDA 510(k) submissions and EU MDR technical documentation.
- Integrate regulatory requirements into early product development, including design controls, risk management, and verification/validation planning.
- Act as the regulatory authority within cross-functional teams, partnering with engineering, quality, and clinical departments.
- Serve as a primary regulatory contact with health authorities, including the FDA and EU Notified Bodies.
- Oversee the preparation and submission readiness of regulatory dossiers.
- Support post-market regulatory activities such as reporting, audits, and compliance initiatives.
- Mentor regulatory staff and promote continuous process improvement.
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