Senior Manager, Regulatory Affairs

Accountabilities

• Provide strategic regulatory leadership for medical device portfolios, ensuring compliance with global regulations while supporting innovation, product development, and market access objectives.
• Develop and execute comprehensive global regulatory strategies aligned with business goals, product roadmaps, and market access requirements.
• Lead regulatory pathways for U.S., EU, and international markets, including FDA Class I and II submissions, 510(k) processes, and EU MDR technical documentation.
• Integrate regulatory requirements into early product development phases, including design controls, risk management, verification and validation planning, and technical documentation.
• Identify regulatory risks, emerging requirements, and compliance challenges while developing effective mitigation strategies.
• Act as the regulatory authority within cross-functional product teams, partnering with engineering, quality, operations, marketing, and clinical teams.
• Evaluate regulatory impacts of product changes, manufacturing updates, supplier changes, labeling revisions, and lifecycle activities.
• Serve as a primary regulatory contact with health authorities, including FDA, EU Notified Bodies, and other international regulatory organizations.
• Support post-market regulatory activities, including reporting obligations, corrective actions, field actions, inspections, audits, and compliance initiatives.
• Mentor regulatory professionals and promote continuous improvement of regulatory processes, tools, and best practices.
• Represent Regulatory Affairs across the organization by providing strategic guidance and regulatory expertise.

Requirements

• An experienced medical device regulatory leader with a strong understanding of global compliance requirements and a proven ability to guide complex regulatory initiatives.
• Excellent communication skills, strategic judgment, and experience operating in global, matrixed environments.
• Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, or a related discipline; advanced degree preferred.
• 8-10+ years of progressive regulatory affairs experience within the medical device industry.
• Demonstrated experience leading FDA Class I and II submissions, including 510(k) submissions.
• Experience with EU MDR (2017/745) technical documentation, conformity assessments, and global regulatory frameworks.
• Direct experience engaging with FDA and EU Notified Bodies; experience with additional international regulatory authorities is preferred.
• Strong knowledge of FDA regulations, including 21 CFR 820/QMSR, 21 CFR 807, 803, and 806.
• Deep understanding of ISO 13485, ISO 14971, quality systems, risk management, complaint handling, and regulatory reporting requirements.
• Experience supporting FDA inspections, audits, and regulatory compliance activities.
• Strong regulatory writing, documentation oversight, and submission planning skills.
• Ability to align regulatory strategies with engineering, quality, and business priorities.
• Excellent leadership, mentoring, negotiation, and stakeholder management abilities.
• Strong analytical, organizational, and problem-solving skills with the ability to manage multiple priorities.
• RAC certification or equivalent regulatory certification is a plus.
• Willingness to travel periodically (approximately 20%) for audits, regulatory meetings, and collaboration activities.

Benefits

• Competitive salary range of approximately $161,920 - $202,400, depending on experience and location.
• Target annual bonus opportunity of 25%.
• Remote work flexibility.
• Comprehensive health, dental, and vision insurance coverage.
• 401(k) retirement plan with company matching contributions.
• Paid time off and holiday benefits.
• Wellness programs and health assistance resources.
• Life insurance coverage.
• Short-term and long-term disability benefits.
• Health and dependent care flexible spending accounts.
• Commuter benefits.
• Parental and caregiver leave programs.
• Tuition reimbursement opportunities.
• Opportunity to work on impactful healthcare technologies within a global and collaborative environment.