regulatory-affairs-head

name	regulatory-affairs-head
description	Manage — Senior Regulatory Affairs Manager for HealthTech and MedTech companies. Prepares FDA 510(k), De Novo, and PMA submission packages; analyzes regulatory pathways for new medical devi
triggers	["regulatory strategy","FDA submission","EU MDR","510(k)","PMA approval","CE marking","regulatory pathway","market access","clinical evidence","regulatory intelligence","submission planning","notified body"]
executor	HYBRID
skill_id	business.ra-qm-team.regulatory-affairs-head
status	ADOPTED
security	{"level":"high","pii":false,"approval_required":true}
anchors	["business"]
tier	2
input_schema	[{"name":"code_or_task","type":"string","description":"Code snippet, script, or task description to process","required":true}]
output_schema	[{"name":"plan","type":"string","description":"Strategic plan or design document"},{"name":"next_steps","type":"array","description":"List of recommended next steps"}]

Head of Regulatory Affairs

Regulatory strategy development, submission management, and global market access for medical device organizations.

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Table of Contents

• Regulatory Strategy Workflow
• FDA Submission Workflow
• EU MDR Submission Workflow
• Global Market Access Workflow
• Regulatory Intelligence Workflow
• Decision Frameworks
• Tools and References

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Regulatory Strategy Workflow

Develop regulatory strategy aligned with business objectives and product characteristics.

Workflow: New Product Regulatory Strategy

1. Gather product information:
   • Intended use and indications
   • Device classification (risk level)
   • Technology platform
   • Target markets and timeline
2. 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
3. Determine optimal regulatory pathway:
   • Compare submission types (510(k) vs De Novo vs PMA)
   • Assess predicate device availability
   • Evaluate clinical evidence requirements
4. Develop regulatory timeline with milestones
5. Estimate resource requirements and budget
6. Identify regulatory risks and mitigation strategies
7. Obtain stakeholder alignment and approval
8. 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