Senior Regulatory Affairs Specialist

🔥 2 minutes ago

🌐 United States, Canada – Remote

🇺🇸 United States – Remote 🇨🇦 Canada – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 15%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Function Health

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2022

🏥 Healthcare

👥 B2C

🔥 Funding within the last year

💰 $450M Debt Financing on 2026-07

Healthcare • B2C

Function Health is a consumer-focused healthcare company that provides comprehensive, subscription-based diagnostic testing and imaging services. For $365/year it offers 160+ lab tests (performed at 2,000+ labs or via mobile phlebotomy) and access to MRI/CT imaging, with results explained by physicians and supported by AI and tools to share with clinicians. The service is HSA/FSA-eligible and emphasizes early detection and longitudinal monitoring of hundreds to thousands of conditions through recurring testing and clinician interpretation.

📋 Description

• Partner with product managers from the requirements stage to set the regulatory path 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, such as 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 clear direction for teams • Build lightweight regulatory processes and templates for product and research teams • Work across lab testing, imaging, and AI-enabled products • Report to the Principal Regulatory Affairs Specialist / Director, Regulatory Affairs

🎯 Requirements

• 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, plus 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, and the ability to turn regulatory requirements into practical guidance for product, engineering, and clinical teams • Comfortable using AI tools to speed up regulatory work, with the judgment to verify and correct their outputs • A bias toward action, and comfort prioritizing across several concurrent projects in a fast-moving environment • AI/ML-enabled device experience, including predetermined change control plans and performance evaluation • Laboratory-developed tests, CLIA, or in vitro diagnostics • Imaging devices • Device cybersecurity and post-market obligations, including complaint handling and adverse event reporting • IRB submissions and oversight of human subjects research • MDSAP audit experience • RAC certification and experience at a startup or consumer health company

🏖️ Benefits

• Competitive Base Salary • Stock options • Comprehensive health, dental, and vision plans for you and your family • Flexible work environment • Team off-sites and wellness initiatives • Competitive vacation policy • A culture that emphasizes continuous learning and personal growth • Flexible working hours • Dynamic work environment where creativity and innovation are encouraged

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume