Health Technology and Medical Devices Medical Device Regulatory Affairs Manager
HTMD.GEN.M3
M3M3 — Senior Managermedium0.70draftglobalv1
Ensures that all medical devices and diagnostic products comply with applicable regulatory requirements and quality standards across target markets.
Summary
Ensures that all medical devices and diagnostic products comply with applicable regulatory requirements and quality standards across target markets.
Level — M3 — Senior Manager
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
Core outputs
No core outputs recorded yet.
Components
Responsibilities10
- Develop regulatory plans for new devices/diagnosticscommonlevel
- Compile and submit regulatory applicationscommonlevel
- Liaise with regulatory agenciescommonlevel
- Monitor and interpret changes in global medical device regulationscommonlevel
- Oversee the company’s quality management systemcommonlevel
- Analyze customer needs and industry trendscommonlevel
- Define the product vision and value propositioncommonlevel
- Collaborate with engineering on requirements and specificationscommonlevel
- Partner with marketing and sales to position the productcommonlevel
- Monitor product performance and user feedback post-launchcommonlevel
Tasks6
- Develop and implement regulatory strategiescommonlevel
- Submit regulatory applicationscommonlevel
- Maintain compliance with global regulationscommonlevel
- Develop product strategiescommonlevel
- Collaborate on product specificationscommonlevel
- Monitor product success post-launchcommonlevel
Skills10
- Regulatory planningcommonlevel
- Application submissioncommonlevel
- Agency liaisoncommonlevel
- Regulatory monitoringcommonlevel
- Quality managementcommonlevel
- Product strategy developmentcommonlevel
- Market analysiscommonlevel
- Cross-functional collaborationcommonlevel
- Customer engagementcommonlevel
- Performance monitoringcommonlevel
Knowledge10
- FDA regulationscommonlevel
- Global regulatory standardscommonlevel
- Quality management systemscommonlevel
- Regulatory documentationcommonlevel
- Ethical compliancecommonlevel
- Medical device market trendscommonlevel
- Product development lifecyclecommonlevel
- Customer needs analysiscommonlevel
- Value proposition designcommonlevel
- User feedback integrationcommonlevel
competency10
- Analytical skillscommonlevel
- Attention to detailcommonlevel
- Communicationcommonlevel
- Project managementcommonlevel
- Ethical Judgmentcommonlevel
- Strategic planningcommonlevel
- Communication & trainingcommonlevel
- Data-driven decision makingcommonlevel
- Collaborationcommonlevel
- Customer Focuscommonlevel
qualification7
- Bachelor’s or Master’s in Biomedical Engineering, Life Sciences, or Regulatory Affairscommonlevel
- 5+ years experience in medical device regulatory affairscommonlevel
- In-depth knowledge of U.S. FDA medical device regulationscommonlevel
- Professional certification (RAC – Regulatory Affairs Certification)commonlevel
- Bachelor’s degree (Engineering or Science field preferred) and/or MBAcommonlevel
- 3-5+ years of experience in product managementcommonlevel
- Familiarity with the medical device development processcommonlevel
Title aliases
| Alias | Type | Confidence | Approved |
|---|---|---|---|
| Health Technology and Medical Devices Medical Device Regulatory Affairs Manager | common | medium0.60 | — |
| Health Technology and Medical Devices Medical Device Product Manager | common | medium0.60 | — |
Classification mappings
O*NET / SOC
- code=15-0000title=Computer & Mathematical Occupationssource=inferred_from_superfunctionreviewStatus=needs_review