Staff Regulatory Affairs Engineer
Leads regulatory strategy, authorship, and submissions (510(k), De Novo) for AI/ML Software as a Medical Device. Partners with Product, Clinical, and Engineering teams to ensure FDA compliance and QMS maintenance. Requires 7+ years in med device regulatory affairs with SaMD focus and bachelor's degree.
About the job
Responsibilities
- Lead the planning, authorship, and submission of regulatory filings (510(k), De Novo, Q-Submissions) for AI/ML-enabled software.
- Develop and execute regulatory strategies for new product introductions and major software updates.
- Participate in Design Reviews and Change Control Boards to assess regulatory impact of software changes, evaluating AI models and retraining pipelines.
- Support maintenance of Quality Management System (QMS) ensuring compliance with 21 CFR 820 and ISO 13485.
- Review and approve labeling, marketing materials, and user manuals.
- Monitor post-market performance of AI models and lead assessments for regulatory reporting (eMDRs).
- Educate cross-functional teams on regulatory principles.
Basic Qualifications
- Education: Bachelor’s degree in Biomedical Engineering, Software Engineering, Regulatory Science, or related field.
- Experience: 7+ years in Regulatory Affairs in medical device industry, with 3+ years in SaMD or Digital Health.
- Proven track record of authoring and clearing US FDA Class II submissions (510(k) or De Novo).
- Experience interfacing with FDA reviewers.
- Technical fluency in software architecture, cloud infrastructure, AI/ML concepts; familiarity with IEC 62304 and FDA Software Validation Guidance.
Preferred Qualifications
- Direct experience with regulatory submissions involving Machine Learning, Deep Learning, or Computer Vision.
- Familiarity with Good Machine Learning Practice (GMLP) and Predetermined Change Control Plans (PCCP).
- Experience with international registrations (EU MDR, Health Canada).
- Ability to review statistical analysis plans and clinical validation reports.
- Experience in Agile/Scrum environments.
Skills
Fda 510(K), De Novo, Predetermined Change Control Plans, Pccp, Ai/Ml Samd, Iec 62304, Iso 13485, 21 Cfr 820, Good Machine Learning Practice, Gmlp, Quality Management System, Qms, Software Validation
Similar jobs
Shield AI
Melbourne, Australia
Leads systems engineering and model-based architecture work for autonomy, perception, and mission-level solutions. The role requires substantial systems engineering experience, STEM education, MBSE expertise, and strong cross-functional communication.
Akur8
New York, NY
Senior Life Actuary responsible for designing and maintaining Life, Annuity, and Health actuarial models, supporting client onboarding, demos, and technical guidance. Requires ASA/FSA-level qualification, 7+ years of relevant experience, actuarial platform expertise, and strong communication skills.
Gusto
San Francisco, CALead AV Engineer owning multi-site audiovisual standards, infrastructure, event production, and the Zoom-to-Google Meet migration. The role requires 8+ years of AV engineering experience, deep control/audio/video expertise, and strong live-event and vendor leadership.
Coalition Security
United States
Underwrites complex cyber and Technology E&O risks for large enterprise accounts, leads broker and client negotiations, and shapes portfolio strategy. Requires at least five years of underwriting experience, strong executive communication, and demonstrated mentorship of other underwriters.
Coalition Security
Canada
Leads complex reinsurance treaty pricing, actuarial model development, and pricing risk governance while translating analytical insights into business recommendations. Requires 8+ years of insurance pricing experience, substantial reinsurance experience, and ACAS or FCAS certification.