Sr Manager, Regulatory Affairs

Job Description

• 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.
• Accountabilities 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
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