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 is a high-impact regulatory leadership role within a fast-scaling, innovation-driven healthcare environment operating at the intersection of digital health, medical products, and pharmaceutical services. You will serve as a key technical authority responsible for ensuring regulatory compliance while enabling rapid product innovation across complex healthcare offerings. The role requires strong expertise in FDA pathways, cross-jurisdictional regulatory frameworks, and hands-on submission leadership. You will act as the bridge between product development, legal, clinical, and operational teams to translate new healthcare solutions into compliant, scalable offerings. In this position, you will also help shape regulatory strategy in a fast-evolving environment where agility and precision are equally critical. This is a highly autonomous role suited for a regulatory expert who thrives in ambiguity and high-growth settings.

You will own end-to-end regulatory strategy and execution across product development, submissions, and compliance operations in a complex, multi-regulatory healthcare ecosystem.

• Lead FDA premarket regulatory strategy and execution, with a primary focus on preparing, authoring, and managing 510(k) submissions through clearance.
• Translate product innovation into compliant regulatory filings, ensuring alignment across legal, clinical, and operational stakeholders.
• Act as the primary regulatory liaison for federal and state agencies, including audits, inspections, and submission-related inquiries.
• Operationalize compliance across FDA (device, drug, compounding) and CMS/CLIA frameworks, ensuring ongoing regulatory readiness.
• Build and maintain a scalable regulatory “playbook” to support evolving product lines and ensure proactive compliance across jurisdictions.
• Collaborate cross-functionally with product, legal, clinical, and operations teams to integrate regulatory requirements into development lifecycles.
• Monitor and interpret evolving regulatory landscapes to anticipate risks and guide strategic decisions.
• Support international and multi-jurisdictional regulatory considerations where applicable.

Requirements:

This role requires deep FDA regulatory expertise, strong submission experience, and the ability to operate autonomously in a fast-paced, evolving healthcare environment.

• 12+ years of experience in Regulatory Affairs, with strong emphasis on medical devices and in vitro diagnostics (IVD).
• Proven track record of successfully leading and authoring FDA 510(k) submissions, with demonstrated clearance success.
• Deep working knowledge of FDA, DEA, CMS/CLIA, and FTC regulatory frameworks.
• Experience in pharmacy compounding and/or international regulatory environments is a strong plus.
• Advanced degree in Regulatory Affairs, Life Sciences, Law, or a related field, or equivalent professional experience.
• Strong ability to operate independently and drive regulatory strategy with minimal oversight.
• High adaptability in fast-paced, high-growth environments with shifting product roadmaps.
• Excellent communication skills with the ability to translate complex regulatory requirements into actionable business guidance.
• Strong cross-functional collaboration skills across legal, clinical, product, and operational teams.
• Strategic mindset with strong attention to detail and executional rigor.

Benefits:

• Competitive salary and equity compensation for full-time roles
• Comprehensive health coverage including medical, dental, and vision insurance
• Unlimited PTO, company holidays, and quarterly mental health days
• 401(k) plan with employer matching contribution
• Employee Stock Purchase Program (ESPP)
• Paid parental leave
• Offsite team retreats and collaborative company gatherings
• Flexible, people-first work environment focused on well-being and impact.