Senior Regulatory Affairs Specialist

This is a fully remote position, open to applicants in United States, +1 more country.

📋 Description

• Collaborate with product managers from the initial requirements phase to establish the regulatory pathway for new features.

• Evaluate member-facing claims, user experiences, and AI-generated outputs in relation to general wellness, clinical decision support, and medical device regulations.

• Prepare regulatory launch reviews and necessary documentation for approval.

• Author and coordinate sections of 510(k), De Novo, and Pre-Submission packages.

• Assist in the documentation related to design control, risk management, and planning for verification and validation evidence.

• Provide support for regulatory strategy, determinations, and submissions for international markets, including the EU and UK.

• Help maintain elements of the quality management system that assist regulatory activities, including document control, design history files, CAPA input, and readiness for audits.

• Conduct assessments of regulatory changes for software, models, and labeling updates for cleared products.

• Maintain trackers for submissions, device determinations, change assessment logs, and correspondence with agencies.

• Keep abreast of FDA guidance and policies concerning digital health and AI-enabled devices, translating this information into clear directives for teams.

• Develop streamlined 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 of Regulatory Affairs.

⛳️ Requirements

• Over 5 years of experience in regulatory affairs concerning medical devices, software as a medical device (SaMD), or diagnostics.

• A bachelor's degree in engineering, life sciences, or a related technical discipline.

• Practical experience with 510(k), De Novo, or Pre-Submission tasks, including the preparation of submission content.

• Familiarity with 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.

• Knowledge of international medical device regulations, including EU MDR and UK MHRA requirements.

• Understanding of quality management system requirements under ISO 13485 and 21 CFR Part 820 (QMSR).

• Experience in reviewing labeling, marketing materials, and in-product claims.

• Strong writing skills, with the ability to translate regulatory requirements into actionable guidance for product, engineering, and clinical teams.

• Proficient in using AI tools to expedite regulatory tasks, with the discretion to validate and amend their outputs.

• A proactive attitude, capable of prioritizing multiple concurrent projects in a fast-paced environment.

• Experience with AI/ML-enabled devices, including established change control plans and performance evaluations.

• Knowledge of laboratory-developed tests, CLIA, or in vitro diagnostics.

• Familiarity with imaging devices.

• Understanding of device cybersecurity and post-market responsibilities, including complaint management and adverse event reporting.

• Experience with IRB submissions and oversight of research involving human subjects.

• MDSAP audit experience.

• RAC certification and experience in a startup or consumer health company setting.

🏝️ Benefits

• Competitive base salary.

• Stock options.

• Comprehensive health, dental, and vision coverage for you and your family.

• Flexible work environment.

• Team off-sites and wellness initiatives.

• Competitive vacation policy.

• A culture that promotes continuous learning and personal development.

• Flexible working hours.

• A dynamic work environment that encourages creativity and innovation.