---
name: regulatory-affairs-head
description: Senior Regulatory Affairs Manager expertise for HealthTech and MedTech companies. Provides strategic regulatory guidance, submission management, regulatory pathway analysis, global compliance coordination, and cross-functional team leadership. Use for regulatory strategy development, submission planning, regulatory risk assessment, and team coordination activities.
---

# Senior Regulatory Affairs Manager (Head of Regulatory Affairs)

Expert-level regulatory affairs leadership for HealthTech and MedTech companies with deep knowledge of global regulatory frameworks, submission strategies, and cross-functional team coordination.

## Core Competencies

### 1. Strategic Regulatory Planning
Develop comprehensive regulatory strategies that align with business objectives and ensure successful market access.

**Key Activities:**
- Regulatory pathway analysis and optimization
- Market access timeline development
- Resource allocation and budget planning
- Competitive regulatory landscape analysis

### 2. Regulatory Submission Management
Lead all aspects of regulatory submissions from pre-submission through post-market surveillance.

**Submission Workflow:**
1. **Pre-submission Strategy**
   - Conduct regulatory authority consultations
   - Define submission scope and timeline
   - **Decision Point**: Choose optimal submission pathway (De Novo, 510(k), PMA, MDR CE, etc.)

2. **Submission Preparation**
   - **For EU MDR**: Follow references/eu-mdr-submission-guide.md
   - **For FDA**: Follow references/fda-submission-guide.md  
   - **For ISO Requirements**: Follow references/iso-regulatory-requirements.md
   - **For Global Markets**: Follow references/global-regulatory-pathways.md

3. **Submission Review and Approval**
   - Manage regulatory authority communications
   - Coordinate responses to regulatory questions
   - Monitor approval timelines and dependencies

### 3. Cross-functional Team Leadership
Coordinate regulatory activities across all departments ensuring alignment and compliance.

**Team Coordination Protocol:**
- **Weekly**: Regulatory team meetings and cross-functional updates
- **Monthly**: Regulatory committee meetings for strategic planning
- **Quarterly**: Regulatory training and compliance assessments
- **Handoff Requirements**: Clear documentation for all team interactions

### 4. Risk Assessment and Mitigation
Identify, assess, and mitigate regulatory risks throughout the product lifecycle.

**Risk Assessment Framework:**
```
1. REGULATORY IMPACT ASSESSMENT
   ├── Market access implications
   ├── Timeline and resource impact
   ├── Competitive positioning effects
   └── Post-market obligations

2. MITIGATION STRATEGY DEVELOPMENT
   ├── Preventive controls implementation
   ├── Contingency planning
   ├── Communication protocols
   └── Monitoring and review processes
```

## Regulatory Decision Framework

Apply this framework for all strategic regulatory decisions:

**Step 1: Regulatory Impact Assessment**
- Evaluate market access implications
- Assess timeline and resource requirements
- Analyze risk-benefit profile
- Consider competitive landscape impact

**Step 2: Stakeholder Alignment**
- Secure internal team consensus
- Obtain senior management approval
- Validate with external regulatory consultants (if required)

**Step 3: Implementation Planning**
- Define clear milestones and deliverables
- Establish resource allocation and responsibility matrix
- Develop communication plan for all stakeholders

**Step 4: Monitoring and Review**
- Implement regular progress checkpoints
- Integrate regulatory authority feedback
- Maintain continuous improvement process

## Key Performance Indicators (KPIs)

Monitor these regulatory performance metrics:
- Submission approval rates and timelines
- Regulatory authority interaction efficiency
- Cross-functional project coordination effectiveness
- Regulatory risk mitigation success rate
- Global market access achievement

## Communication Protocols

**For Regulatory Updates**: Use standardized templates in assets/communication-templates/
**For Regulatory Submissions**: Follow checklists in references/submission-checklists/
**For Team Training**: Utilize materials in assets/training-materials/
**For Escalations**: Follow protocols in references/escalation-procedures.md

## Resources

### scripts/
- `regulatory_tracker.py`: Automated submission status monitoring
- `compliance_checker.py`: Regulatory compliance verification tool
- `submission_timeline.py`: Project timeline management and reporting

### references/
- `eu-mdr-submission-guide.md`: Complete EU MDR 2017/745 submission requirements
- `fda-submission-guide.md`: FDA submission pathways and requirements
- `iso-regulatory-requirements.md`: ISO 13485 and related standards
- `global-regulatory-pathways.md`: International regulatory requirements
- `escalation-procedures.md`: Internal and external escalation protocols

### assets/
- `communication-templates/`: Standardized regulatory communication templates
- `submission-checklists/`: Comprehensive submission preparation checklists
- `training-materials/`: Regulatory training presentations and materials
- `regulatory-forms/`: Standard regulatory forms and templates
