Regulatory Affairs Manager, Scientific Devices

Career Guide
Leads regulatory strategy and submissions for scientific and medical devices. Oversees 510(k)/De Novo/PMA or CE-marking dossiers, interfaces with FDA and notified bodies, maintains compliance across design changes and post-market activities, and manages a team to meet launch and lifecycle timelines.

Key Responsibilities

  • Define global regulatory strategy for new and changed devices/IVDs
  • Author and manage FDA submissions (510(k), De Novo, PMA)
  • Prepare EU MDR/IVDR technical documentation and liaise with Notified Bodies
  • Assess design changes and lead regulatory change management
  • Maintain registrations, listings, labeling, and UDI compliance
  • Monitor post-market surveillance and file MDRs/Field Actions when needed
  • Track regulatory changes and advise R&D, QA, and commercial teams
  • Lead, mentor, and resource-plan for regulatory specialists/coordinators

Career Progression

Can Lead To
Senior Regulatory Affairs Manager
Director of Regulatory Affairs
Head of Regulatory Affairs
Transition Opportunities
Quality Assurance Manager (Medical Devices)
Clinical Affairs Manager
Product Manager (Medical Devices)
Regulatory Compliance Manager

Common Skill Gaps

Often Missing Skills
Hands-on authorship of 510(k)/De Novo/PMA dossiersEU MDR conformity assessment and tech file readinessRisk management implementation per ISO 14971Regulatory change control tied to design controlsPost-market surveillance and vigilance reporting
Development SuggestionsComplete targeted RAPS/Emergo courses (510(k), EU MDR, ISO 14971) and co-author a real or mock submission; participate in ISO 13485 internal audits and lead a change-control impact assessment to build evidence of applied competency.

Salary & Demand

Median Salary Range
Entry Level$95,000-$115,000
Mid Level$120,000-$145,000
Senior Level$150,000-$185,000
Growth Trend
growing | Device innovation and MDR/QMSR updates keep demand steadily rising

Companies Hiring

Major Employers
MedtronicAbbottThermo Fisher Scientific
Industry Sectors
Medical DevicesDiagnostics & Life SciencesBiotechnology

Recommended Next Steps

1
Pursue RAC (US or Devices) and complete a 510(k) or EU MDR technical documentation course with capstone
2
Partner with QA/R&D to draft two key submission sections (e.g., substantial equivalence, risk/benefit) and build a portfolio artifact
3
Join RAPS and a local device regulatory meetup; request informational interviews with RA leaders at 2–3 device firms to validate requirements and get referrals