Head of Global Regulatory and Quality Affairs

Location Requirement

This role requires physical presence in the US, with periodic travel to India (most of the R&D/QA team is based there). This is not a remote or hybrid-from-a-distance role. FDA inspections and correspondence can require same-day, on-site response.

How the role works: strategize, execute, sustain

Strategize — set the regulatory roadmap. Define the U.S. regulatory pathway for new hardware and software features, and own the strategy that keeps releases on schedule.

Execute — run point with FDA. Lead submissions, respond to FDA correspondence, and own inspections and audits from start to finish.

Sustain — keep the system compliant at scale. Own the quality management system, post-market surveillance, and the security and privacy certifications our customers require.

What you'll Own

Immediate 

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.

Ongoing (permanent function)

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 to have

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.