Sr Manager, Regulatory Affairs

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Sr Manager, Regulatory Affairs based in the United States.

This senior leadership role is responsible for shaping and executing global regulatory strategy across a portfolio of medical imaging software and healthcare technology solutions. You will play a key role in ensuring regulatory compliance across the full product lifecycle, from development and design changes to post-market surveillance and market authorization. The role involves close collaboration with cross-functional teams including Product, Engineering, Quality, and Clinical stakeholders to ensure regulatory requirements are fully embedded into product strategy and execution. You will also act as a key point of contact for regulatory authorities and notified bodies across multiple regions. In addition to strategic oversight, you will lead a high-performing team and help mature regulatory processes in a fast-evolving SaaS and SaMD environment. This is a highly impactful position for someone who thrives at the intersection of healthcare, software, and global regulatory complexity.

• 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.

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
• Infertility, parental, and family support benefits
• Tuition reimbursement, employee assistance programs, and life insurance coverage
• Inclusive, equal opportunity workplace with strong support for accessibility and accommodations