Regulatory Affairs Head | Skills Pool
Regulatory Affairs Head Senior Regulatory Affairs Manager for HealthTech and MedTech companies. Provides regulatory strategy development, submission management, pathway analysis, global compliance coordination, and cross-functional team leadership.
Tonybleything76 0 Sterne 02.02.2026 Beruf Kategorien Vertrieb & Marketing Head of Regulatory Affairs
Regulatory strategy development, submission management, and global market access for medical device organizations.
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Regulatory Affairs Head npx skills add Tonybleything76/more-claude-skills
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Regulatory Strategy Workflow Develop regulatory strategy aligned with business objectives and product characteristics.
Workflow: New Product Regulatory Strategy
Gather product information:
Intended use and indications
Device classification (risk level)
Technology platform
Target markets and timeline
Identify applicable regulations per target market:
FDA (US): 21 CFR Part 820, 510(k)/PMA/De Novo
EU: MDR 2017/745, Notified Body requirements
Other markets: Health Canada, PMDA, NMPA, TGA
Determine optimal regulatory pathway:
Compare submission types (510(k) vs De Novo vs PMA)
Assess predicate device availability
Evaluate clinical evidence requirements
Develop regulatory timeline with milestones
Estimate resource requirements and budget
Identify regulatory risks and mitigation strategies
Obtain stakeholder alignment and approval
Validation: Strategy document approved; timeline accepted; resources allocated
Regulatory Pathway Selection Matrix Factor 510(k) De Novo PMA Predicate Available Yes No N/A Risk Level Low-Moderate Low-Moderate High Clinical Data Usually not required May be required Required Review Time 90 days (MDUFA) 150 days 180 days User Fee ~$22K (2024) ~$135K ~$440K Best For Me-too devices Novel low-risk High-risk, novel
Regulatory Strategy Document Template REGULATORY STRATEGY
Product: [Name]
Version: [X.X]
Date: [Date]
1. PRODUCT OVERVIEW
- Intended use: [Statement]
- Device classification: [Class I/II/III]
- Technology: [Description]
2. TARGET MARKETS
| Market | Priority | Timeline |
|--------|----------|----------|
| USA | 1 | Q1 20XX |
| EU | 2 | Q2 20XX |
3. REGULATORY PATHWAY
- FDA: [510(k) / De Novo / PMA]
- EU: [Class] via [Conformity route]
- Rationale: [Justification]
4. CLINICAL EVIDENCE STRATEGY
- Requirements: [Summary]
- Approach: [Literature / Study / Both]
5. TIMELINE AND MILESTONES
[Gantt or milestone table]
6. RISKS AND MITIGATION
| Risk | Probability | Impact | Mitigation |
|------|-------------|--------|------------|
7. RESOURCE REQUIREMENTS
- Budget: $[Amount]
- Personnel: [FTEs]
- External support: [Consultants, CRO]
FDA Submission Workflow Prepare and submit FDA regulatory applications.
Workflow: 510(k) Submission
Confirm 510(k) pathway suitability:
Predicate device identified
Substantial equivalence supportable
No new intended use or technology concerns
Schedule and conduct Pre-Submission (Q-Sub) meeting if needed
Compile submission package:
Cover letter and administrative information
Device description and intended use
Substantial equivalence comparison
Performance testing data
Biocompatibility (if patient contact)
Software documentation (if applicable)
Labeling and IFU
Conduct internal review and quality check
Prepare eCopy per FDA format requirements
Submit via FDA ESG portal with user fee payment
Monitor MDUFA clock and respond to AI/RTA requests
Validation: Submission accepted; MDUFA date received; tracking system updated
Workflow: PMA Submission
Confirm PMA pathway:
Class III device or no predicate
Clinical data strategy defined
Complete IDE clinical study if required:
IDE approval
Clinical protocol execution
Study report completion
Conduct Pre-Submission meeting
Compile PMA submission:
Administrative and device information
Manufacturing information
Nonclinical studies
Clinical studies
Labeling
Submit original PMA application
Address FDA questions and deficiencies
Prepare for FDA facility inspection
Validation: PMA approved; approval letter received; post-approval requirements documented
FDA Submission Timeline Milestone 510(k) De Novo PMA Pre-Sub Meeting Day -90 Day -90 Day -120 Submission Day 0 Day 0 Day 0 RTA Review Day 15 Day 15 Day 45 Substantive Review Days 15-90 Days 15-150 Days 45-180 Decision Day 90 Day 150 Day 180
Common FDA Deficiencies Category Common Issues Prevention Substantial Equivalence Weak predicate comparison Strong SE argument upfront Performance Testing Incomplete test protocols Follow recognized standards Biocompatibility Missing endpoints ISO 10993 risk assessment Software Inadequate documentation IEC 62304 compliance Labeling Inconsistent claims Early labeling review
EU MDR Submission Workflow Achieve CE marking under EU MDR 2017/745.
Workflow: MDR Technical Documentation
Confirm device classification per MDR Annex VIII
Select conformity assessment route based on class:
Class I: Self-declaration
Class IIa/IIb: Notified Body involvement
Class III: Full NB assessment
Select and engage Notified Body (for Class IIa+)
Compile Technical Documentation per Annex II:
Device description and specifications
Design and manufacturing information
General Safety and Performance Requirements (GSPR) checklist
Benefit-risk analysis and risk management
Clinical evaluation per Annex XIV
Post-market surveillance plan
Establish and document QMS per ISO 13485
Submit application to Notified Body
Address NB questions and coordinate audit
Validation: CE certificate issued; Declaration of Conformity signed; EUDAMED registration complete
MDR Classification Decision Tree Is the device active?
│
Yes─┴─No
│ │
▼ ▼
Is it an Does it contact
implant? the body?
│ │
Yes─┴─No Yes─┴─No
│ │ │ │
▼ ▼ ▼ ▼
III IIb Check Class I
contact (measuring/
type sterile if
and applicable)
duration
Clinical Evidence Requirements by Class Class Clinical Requirement Documentation I Clinical evaluation (CE) CE report IIa CE with literature focus CE report + PMCF plan IIb CE with clinical data CE report + PMCF + clinical study (some) III CE with clinical investigation CE report + PMCF + clinical investigation
Notified Body Selection Criteria Criterion Consideration Scope Device category expertise Capacity Availability and review timeline Experience Track record in your technology Geography Proximity for audits Cost Fee structure transparency Communication Responsiveness and clarity
Global Market Access Workflow Coordinate regulatory approvals across international markets.
Workflow: Multi-Market Submission Strategy
Define target markets based on business priorities
Sequence markets for efficient evidence leverage:
Phase 1: FDA + EU (reference markets)
Phase 2: Recognition markets (Canada, Australia)
Phase 3: Major markets (Japan, China)
Phase 4: Emerging markets
Identify local requirements per market:
Clinical data acceptability
Local agent/representative needs
Language and labeling requirements
Develop master technical file with localization plan
Establish in-country regulatory support
Execute parallel or sequential submissions
Track approvals and coordinate launches
Validation: All target market approvals obtained; registration database updated
Market Priority Matrix Market Size Complexity Recognition Priority USA Large High N/A 1 EU Large High N/A 1-2 Canada Medium Medium MDSAP 2 Australia Medium Low EU accepted 2 Japan Large High Local clinical 3 China Large Very High Local testing 3 Brazil Medium High GMP inspection 3-4
Documentation Efficiency Strategy Document Type Single Source Localization Required Technical file core Yes Format adaptation Risk management Yes None Clinical data Yes Bridging assessment QMS certificate Yes (ISO 13485) Market-specific audit Labeling Master label Translation, local requirements IFU Master content Translation, local symbols
Regulatory Intelligence Workflow Monitor and respond to regulatory changes affecting product portfolio.
Workflow: Regulatory Change Management
Monitor regulatory sources:
FDA Federal Register, guidance documents
EU Official Journal, MDCG guidance
Notified Body communications
Industry associations (AdvaMed, MedTech Europe)
Assess relevance to product portfolio
Evaluate impact:
Timeline to compliance
Resource requirements
Product changes needed
Develop compliance action plan
Communicate to affected stakeholders
Implement required changes
Document compliance status
Validation: Compliance action plan approved; changes implemented on schedule
Regulatory Monitoring Sources Source Type Frequency FDA Federal Register Regulations, guidance Daily FDA Device Database 510(k), PMA, recalls Weekly EU Official Journal MDR/IVDR updates Weekly MDCG Guidance EU implementation As published ISO/IEC Standards updates Quarterly Notified Body Audit findings, trends Per interaction
Impact Assessment Template REGULATORY CHANGE IMPACT ASSESSMENT
Change: [Description]
Source: [Regulation/Guidance]
Effective Date: [Date]
Assessment Date: [Date]
Assessed By: [Name]
AFFECTED PRODUCTS
| Product | Impact | Action Required | Timeline |
|---------|--------|-----------------|----------|
| [Name] | [H/M/L]| [Description] | [Date] |
COMPLIANCE ACTIONS
1. [Action 1] - Owner: [Name] - Due: [Date]
2. [Action 2] - Owner: [Name] - Due: [Date]
RESOURCE REQUIREMENTS
- Budget: $[Amount]
- Personnel: [Hours/FTEs]
APPROVAL
Regulatory: _________________ Date: _______
Management: _________________ Date: _______
Decision Frameworks
Pathway Selection Decision Tree Is predicate device available?
│
Yes─┴─No
│ │
▼ ▼
Is device Is risk level
substantially Low-Moderate?
equivalent? │
│ Yes─┴─No
Yes─┴─No │ │
│ │ ▼ ▼
▼ ▼ De Novo PMA
510(k) Consider required
De Novo
or PMA
Pre-Submission Meeting Decision Factor Schedule Pre-Sub Skip Pre-Sub Novel Technology ✓ New Intended Use ✓ Complex Testing ✓ Uncertain Predicate ✓ Clinical Data Needed ✓ Well-established ✓ Clear Predicate ✓ Standard Testing ✓
Regulatory Escalation Criteria Situation Escalation Level Action Submission rejection VP Regulatory Root cause analysis, strategy revision Major deficiency Director Cross-functional response team Timeline at risk Management Resource reallocation review Regulatory change VP Regulatory Portfolio impact assessment Safety signal Executive Immediate containment and reporting
Scripts Regulatory Tracker Features:
Track multiple submissions across markets
Monitor status and target dates
Identify overdue submissions
Generate status reports
References Document Content fda-submission-guide.md FDA pathways, requirements, review process eu-mdr-submission-guide.md MDR classification, technical documentation, clinical evidence global-regulatory-pathways.md Canada, Japan, China, Australia, Brazil requirements iso-regulatory-requirements.md ISO 13485, 14971, 10993, IEC 62304, 62366 requirements
KPI Target Calculation First-time approval rate >85% (Approved without major deficiency / Total submitted) × 100 On-time submission >90% (Submitted by target date / Total submissions) × 100 Review cycle compliance >95% (Responses within deadline / Total requests) × 100 Regulatory hold time <20% (Days on hold / Total review days) × 100
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