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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:

Copy1. 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