Head of Global Regulatory and Quality Affairs

• Serve as the primary point of contact for  QMS structuring and implementation and regulatory projects working directly alongside regulatory counsel.

• Conduct or oversee an independent internal assessment of current regulatory and quality structure.

• Own and implement CAPA processes.

• US FDA regulatory strategy: device classification, pathway selection, and 510(k)/De Novo/PMA submissions for connected hardware and companion software (including SaMD).

• Quality Management System: Instrument QMS under 21 CFR 820 and ISO 13485, including design controls, document control, and CAPA. Build the playbook and advise cross-functional teams.

• Direct and audit compliance: work performed by distributed engineering and QA teams, including offshore teams, while based in the US to interface directly with FDA.

• SOC 2 Type II and HIPAA compliance as ongoing programs.

• Post-market compliance: surveillance, adverse event reporting, and complaint handling.

• Report regulatory and quality health directly to the CEO and to an independent board member on a defined cadence.

• Lead FDA audits and inspections — be the primary point of contact for FDA inspections, and prepare the team and documentation.

• Advise Product and Engineering — review design changes, new features, and hardware revisions for regulatory impact.

• Partner with global teams on international standards — where relevant, align our documentation and quality systems with standards used by international teams and partners (e.g., ISO, MDR-adjacent practices), even though the core mandate is U.S. FDA compliance.

• Other international markets: Continue ongoing CE compliance and enable other international regulatory clearances based on business goals.

• Report regulatory health to leadership — submission status, audit readiness, and certification timelines, translated into clear updates for the CEO/Founder and other stakeholders.

• Team — nurture and build on the team of regulatory affairs specialists.

Experience we're looking for

• 8-12+ years in medical device regulatory affairs, with direct hands-on US FDA experience across the full device lifecycle.

• Direct experience with connected hardware and software/SaMD, not just single-product or paper-based devices.

• Experience auditing and building a QMS under 21 CFR 820 and/or ISO 13485, ideally from early stage.

• SOC 2 Type II and HIPAA compliance programs, either owning them directly or working closely with the teams that do.

• Exposure to global regulatory teams or international standards is a strong plus, though the core requirement is deep U.S. FDA fluency.

• A track record leading or directly supporting FDA submissions, inspections and audits, with outcomes you can speak to.

• 8–12+ years in regulatory affairs for medical devices, with hands-on U.S. FDA experience across the full device lifecycle — classification, submissions (510(k)/De Novo/PMA), and post-market.

• Comfortable being the sole regulatory owner at a scaling company — hands-on with submissions and documentation, not just strategy.

Nice Bonus 

• RAC (Regulatory Affairs Certification), US Medical Devices track (RAPS)

• ASQ CQA or CBA

• ISO 13485 Lead Auditor training (Exemplar Global, BSI, TUV, or equivalent)

• AAMI training on 21 CFR 820 / ISO 14971

• Experience with international standards (ISO, MDR-adjacent) supporting offshore engineering teams

Skills that set you up to win

• FDA fluency. You know the submission pathways, inspection process, and post-market obligations well enough to run them without hand-holding.

• Builder mindset. You've built QMS and regulatory processes from scratch, not just maintained an existing one.

• Compliance rigor. You hold the line on documentation and quality standards even as the team moves fast.

• Security and privacy fluency. You're comfortable owning SOC 2 and HIPAA as living programs, not checkbox exercises.

• Cross-functional comfort. You work naturally with Product, Engineering, Quality, and Clinical to implement regulatory rigor at the design stage.

• Global standards awareness. You can translate international requirements into practical guidance for a US-first organization.

• High ownership at founder speed. You move fast, make calls with incomplete information, and take responsibility for outcomes.

• Ethical Advocacy A track record of escalating compliance failures against business pressure, with a specific example you can walk through: what you flagged, what happened when you were overruled, and what you did next.