Sr Manager, Regulatory Affairs

The Sr Manager, Regulatory Affairs role is responsible for shaping and executing global regulatory strategy across a portfolio of medical imaging software and healthcare technology solutions. Key responsibilities include:

1. Develop and execute global regulatory strategies for Software as a Medical Device (SaMD) and healthcare imaging solutions.
2. Oversee regulatory submissions, product registrations, certifications, and communications with global regulatory authorities.
3. Manage submissions, deficiency responses, inspections, audits, and ongoing compliance engagements with regulatory bodies and notified authorities.
4. Ensure ongoing regulatory compliance across post-market activities including vigilance reporting, complaint handling, recalls, and cybersecurity risk response.
5. Partner with Quality, Engineering, Product, and Customer Support teams to embed regulatory requirements into development, release, and lifecycle processes.
6. Lead and mentor a regulatory affairs team, setting clear objectives, developing talent, and strengthening organizational capability and governance standards.

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.

Benefits

• Remote-first work model with flexibility to work from home.
• Competitive salary range: $144,632.60 - $216,948.90 USD.
• Performance-based compensation structure aligned with experience and market benchmarks.
• Health, dental, and vision insurance coverage.
• 401(k) retirement savings plan with employer support.
• Flexible vacation policy and paid leave benefits.
• Inclusive, equal opportunity workplace with strong support for accessibility and accommodations.