Sr. Regulatory Affairs Specialist , Medical Devices Operational Compliance Center (MD-OCC)

What you'll do

• Represents regulatory affairs on product teams, advising on requirements and registrations and preparing submissions to health agencies.
• Assesses product, manufacturing, design, labeling, and promotional changes for regulatory compliance; supports product release and post-market obligations.
• Maintains regulatory and quality compliance systems and supports audits, inspections, licensing, and agency communications.

What they ask for

• 7+ years working directly with engineering teams; 5+ years of technical product or program management and technical program management with software engineering teams.
• Experience with regulatory filings and reports or equivalent, and managing cross-functional programs, processes, and release schedules.
• Bachelor’s Degree in a Scientific discipline (e.g., Biomedical Engineering, life Sciences, Biology) or equivalent qualifications.
• 5 years working within requirements of 21 CFR 820, ISO13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC); 5 years in a regulated industry with Class II and/or Class III devices.

Nice to have

• 5+ years of project management disciplines including scope, schedule, budget, quality, risk, and critical path management.
• Experience with Data & AI technologies, including AI/ML, GenAI, Analytics, Database, and/or Storage; Regulatory Affairs Certification (RAPS).

Pay

171,000.00 - 231,400.00 USD annually (base salary)

Tools

21 CFR 820, ISO13485, Medical Devices Directive (93/42/EEC), IVD Directive (98/79/EC), AI/ML, GenAI, Analytics, Database

AI focus

Preferred experience with Data & AI related technologies, including AI/ML and GenAI.