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.

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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.

Market Intelligence Report

Regulatory Affairs Manager, Scientific Devices is part of the Regulatory Affairs category.Explore our market intelligence report to see how AI and hiring demand are shifting for these roles.

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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

Pursue RAC (US or Devices) and complete a 510(k) or EU MDR technical documentation course with capstone

Partner with QA/R&D to draft two key submission sections (e.g., substantial equivalence, risk/benefit) and build a portfolio artifact

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