regulatory-affairs-head

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.)

1. 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

1. 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

1. MITIGATION STRATEGY DEVELOPMENT

├── Preventive controls implementation

├── Contingency planning

├── Communication protocols

└── Monitoring and review processes

```

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

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

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

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