M3M3 — Senior Manager
Health Technology and Medical Devices Medical Device Regulatory Affairs Manager
Ensures that all medical devices and diagnostic products comply with applicable regulatory requirements and quality standards across target markets.
What this level means
Leads multiple teams or a sub-function; sets goals and owns cross-team execution.
- Scope
- Multiple teams or a sub-function
- Autonomy
- Sets goals within functional strategy
- Complexity
- Multi-team execution and resourcing trade-offs
- Impact
- Sub-function outcomes
- Decision rights
- Owns goals, budget input, and people decisions across teams
- Leadership
- Manages managers and/or several teams
- Typical experience
- 8–12 yrs
What you'd do
- Develop regulatory plans for new devices/diagnostics
- Compile and submit regulatory applications
- Liaise with regulatory agencies
- Monitor and interpret changes in global medical device regulations
- Oversee the company’s quality management system
- Analyze customer needs and industry trends
- Define the product vision and value proposition
- Collaborate with engineering on requirements and specifications
- Partner with marketing and sales to position the product
- Monitor product performance and user feedback post-launch
- Develop and implement regulatory strategies
- Submit regulatory applications
- Maintain compliance with global regulations
- Develop product strategies
- Collaborate on product specifications
- Monitor product success post-launch
Skills, knowledge & tools
- Regulatory planning
- Application submission
- Agency liaison
- Regulatory monitoring
- Quality management
- Product strategy development
- Market analysis
- Cross-functional collaboration
- Customer engagement
- Performance monitoring
- FDA regulations
- Global regulatory standards
- Quality management systems
- Regulatory documentation
- Ethical compliance
- Medical device market trends
- Product development lifecycle
- Customer needs analysis
- Value proposition design
- User feedback integration
- Analytical skills
- Attention to detail
- Communication
- Project management
- Ethical Judgment
- Strategic planning
- Communication & training
- Data-driven decision making
- Collaboration
- Customer Focus
What good looks like
- Bachelor’s or Master’s in Biomedical Engineering, Life Sciences, or Regulatory Affairs
- 5+ years experience in medical device regulatory affairs
- In-depth knowledge of U.S. FDA medical device regulations
- Professional certification (RAC – Regulatory Affairs Certification)
- Bachelor’s degree (Engineering or Science field preferred) and/or MBA
- 3-5+ years of experience in product management
- Familiarity with the medical device development process
Common titles
Health Technology and Medical Devices Medical Device Regulatory Affairs ManagerHealth Technology and Medical Devices Medical Device Product Manager
What it pays
Market-pay benchmarks for this family × level are being recalibrated across all survey sources and will return shortly.
O*NET / SOC: 15-0000 — Computer & Mathematical Occupations (inferred)