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
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Why Apply Through Jobgether?
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