Senior Regulatory Affairs Specialist

Function Health • US - Remote,

1d

About The Position

Function Health is seeking a hands-on regulatory partner to support product and research teams as the company expands across lab testing, imaging, and AI-enabled software. The role sets regulatory paths early in product development, reviews product claims and functionality, supports FDA and international submissions, and maintains audit-ready regulatory records. It works across multiple product areas and helps turn ambiguous regulatory questions into clear, defensible guidance that enables teams to move forward.

Requirements

• At least 5 years of regulatory affairs experience with medical devices, software as a medical device (SaMD), or diagnostics.
• Bachelor's degree in engineering, life sciences, or a related technical field.
• Hands-on experience with 510(k), De Novo, or Pre-Submission work, including preparing submission content.
• Working knowledge of FDA device regulations and guidance, including general wellness, clinical decision support software, and AI-enabled device software, as well as ISO 13485, ISO 14971, and IEC 62304.
• Familiarity with international medical device regulations, such as EU MDR and UK MHRA requirements.
• Working knowledge of quality management system requirements under ISO 13485 and 21 CFR Part 820 (QMSR).
• Experience reviewing labeling, marketing, and in-product claims.
• Clear writing skills and the ability to turn regulatory requirements into practical guidance for product, engineering, and clinical teams.
• Comfort using AI tools to accelerate regulatory work, with the judgment to verify and correct their outputs.
• Bias toward action and comfort prioritizing across several concurrent projects in a fast-moving environment.

Nice To Haves

• Experience with AI/ML-enabled devices, including predetermined change control plans and performance evaluation.
• Experience with laboratory-developed tests, CLIA, or in vitro diagnostics.
• Experience with imaging devices.
• Experience with device cybersecurity and post-market obligations, including complaint handling and adverse event reporting.
• Experience with IRB submissions and oversight of human subjects research.
• MDSAP audit experience.
• RAC certification.
• Experience at a startup or consumer health company.

Responsibilities

• Partner with product managers from the requirements stage to establish regulatory pathways for new features.
• Review member-facing claims, user experience, and AI-generated outputs against general wellness, clinical decision support, and medical device boundaries.
• Prepare regulatory launch reviews and supporting documentation for sign-off.
• Author and coordinate sections of 510(k), De Novo, and Pre-Submission packages.
• Support design control documentation, risk management, and verification and validation evidence planning.
• Support regulatory strategy, determinations, and submissions for international markets, including the EU and UK.
• Help maintain quality management system elements supporting regulatory work, including document control, design history files, CAPA input, and audit readiness.
• Conduct regulatory change assessments for software, model, and labeling updates to cleared products.
• Maintain submission trackers, device determinations, change assessment logs, and agency correspondence.
• Monitor FDA guidance and policy on digital health and AI-enabled devices and translate it into direction for teams.
• Build lightweight regulatory processes and templates for product and research teams.

Benefits

• Competitive base salary.
• Stock options.
• Comprehensive health, dental, and vision plans for employees and their families.
• Flexible work environment and flexible working hours.
• Team off-sites and wellness initiatives.
• Competitive vacation policy.
• A culture emphasizing continuous learning and personal growth.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior