Sr Manager, Regulatory Affairs
New
Based in the United StatesFull-TimeManager
Salary$144,632.60 – $216,948.90 USD
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Job Details
- Experience
- 10+ years of experience in medical device regulatory affairs, healthcare technology, or life sciences; 5+ years of leadership experience
- Required Skills
- Quality Assurance
Requirements
- 10+ years of experience in medical device regulatory affairs, healthcare technology, or life sciences, with significant exposure to Software as a Medical Device (SaMD) or regulated software products.
- 5+ years of leadership experience managing regulatory teams in medium to large, matrixed, and regulated environments.
- Strong expertise in global regulatory frameworks including FDA requirements, EU MDR, ISO 13485, MDSAP, Health Canada regulations, and other international medical device standards.
- Proven experience preparing and managing regulatory submissions, technical documentation, and market authorization processes across multiple regions.
- Deep understanding of software lifecycle processes, risk management, cybersecurity requirements, and relevant standards such as IEC 62304, ISO 14971, and IEC 62366-1.
- Strong ability to interpret complex regulatory requirements and translate them into actionable strategies for cross-functional teams.
- Excellent leadership, communication, and stakeholder management skills with the ability to influence executive and technical audiences.
Responsibilities
- Lead the development and execution of global regulatory strategies for Software as a Medical Device (SaMD) and healthcare imaging solutions, including classification, submission pathways, and market access planning across multiple jurisdictions.
- Oversee regulatory submissions, product registrations, certifications, and communications with global regulatory authorities, ensuring timely and compliant market authorizations.
- Evaluate product changes, including software updates, cybersecurity enhancements, and algorithm modifications, to determine regulatory impact and required filings or notifications.
- Act as primary liaison with regulatory bodies and notified authorities, managing submissions, deficiency responses, inspections, audits, and ongoing compliance engagements.
- Ensure ongoing regulatory compliance across post-market activities including vigilance reporting, complaint handling, recalls, and cybersecurity risk response.
- Partner with Quality, Engineering, Product, and Customer Support teams to embed regulatory requirements into development, release, and lifecycle processes.
- Lead and mentor a regulatory affairs team, setting clear objectives, developing talent, and strengthening organizational capability and governance standards.
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