Head of Regulatory Affairs

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

Regulatory Strategy Workflow

The agent develops regulatory strategy aligned with business objectives and product characteristics.

Workflow: New Product Regulatory Strategy

• Gather product information -- collect intended use, device classification (risk level), technology platform, target markets, and timeline from stakeholders.

• 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 using the pathway selection matrix below -- compare submission types, assess predicate device availability, evaluate clinical evidence requirements.

• Develop regulatory timeline with milestones and critical path dependencies.

• Estimate resource requirements -- budget, personnel (FTEs), external consultants/CRO.

• Identify regulatory risks and define mitigation strategies for each.

• Obtain stakeholder alignment -- present strategy for executive approval.

• Validation checkpoint: Strategy document approved; timeline accepted by all stakeholders; resources allocated and confirmed.

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

Example: Regulatory Strategy Output

REGULATORY STRATEGY

Product: CardioSense Wearable ECG Monitor Version: 1.0 Date: 2026-03-12

1. PRODUCT OVERVIEW

   • Intended use: Continuous ECG monitoring for arrhythmia detection
   • Device classification: Class II (FDA), Class IIa (EU MDR)
   • Technology: Single-lead ECG with ML-based AF detection

2. TARGET MARKETS

   Market	Priority	Timeline
   USA	1	Q3 2026
   EU	2	Q1 2027
   Canada	3	Q2 2027

3. REGULATORY PATHWAY

   • FDA: 510(k) — Predicate: AliveCor KardiaMobile (K142743)
   • EU: Class IIa via Annex IX (QMS) + Annex XI Part A (Product)
   • Rationale: Established predicate supports SE argument; MDR IIa classification per Rule 10 (active diagnostic)

4. CLINICAL EVIDENCE STRATEGY

   • Requirements: SE comparison + analytical performance data
   • Approach: Literature review for AF detection + bench study

5. RISKS AND MITIGATION

   Risk	Probability	Impact	Mitigation
   FDA requests clinical	Medium	High	Pre-Sub meeting to align
   NB capacity delay	High	Medium	Engage NB by Q4 2025
   ML algorithm as SaMD	Medium	High	Follow FDA AI/ML SaMD guidance

FDA Submission Workflow

The agent prepares and submits FDA regulatory applications following established pathways.

Workflow: 510(k) Submission

• Confirm 510(k) pathway suitability -- verify predicate device identified, substantial equivalence supportable, no new intended use or technology concerns.

• Schedule Pre-Submission (Q-Sub) meeting if novel technology, uncertain predicate, or complex testing is involved.

• Compile submission package:

• Cover letter and administrative information

• Device description and intended use

• Substantial equivalence comparison

• Performance testing data

• Biocompatibility (if patient contact, per ISO 10993)

• Software documentation (if applicable, per IEC 62304)

• Labeling and IFU

• Conduct internal review -- quality check all sections against FDA checklist.

• Prepare eCopy per current FDA format requirements.

• Submit via FDA ESG portal with user fee payment.

• Monitor MDUFA clock and respond to AI/RTA requests within deadline.

• Validation checkpoint: Submission accepted (RTA complete); MDUFA goal date received; tracking system updated.

Workflow: PMA Submission

• Confirm PMA pathway -- Class III device or no suitable predicate; clinical data strategy defined.

• Complete IDE clinical study if required -- IDE approval, protocol execution, study report.

• Conduct Pre-Submission meeting with FDA.

• Compile PMA submission -- administrative/device information, manufacturing information, nonclinical studies, clinical studies, labeling.

• Submit original PMA application.

• Address FDA questions and deficiency letters within specified timeframes.

• Prepare for FDA facility inspection -- coordinate with Quality team.

• Validation checkpoint: 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

See: references/fda-submission-guide.md

EU MDR Submission Workflow

The agent achieves CE marking under EU MDR 2017/745.

Workflow: MDR Technical Documentation

• Confirm device classification per MDR Annex VIII rules.

• 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+) -- evaluate scope, capacity, experience, and timeline.

• Compile Technical Documentation per Annex II:

• Device description and specifications

• Design and manufacturing information

• GSPR checklist (General Safety and Performance Requirements)

• Benefit-risk analysis and risk management (ISO 14971)

• 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 logistics.

• Validation checkpoint: CE certificate issued; Declaration of Conformity signed; EUDAMED registration complete.

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

See: references/eu-mdr-submission-guide.md

Global Market Access Workflow

The agent coordinates regulatory approvals across international markets.

Workflow: Multi-Market Submission Strategy

• Define target markets based on business priorities and revenue projections.

• Sequence markets for efficient evidence leverage:

• Phase 1: FDA + EU (reference markets)

• Phase 2: Recognition markets (Canada via MDSAP, Australia via TGA)

• Phase 3: Major markets (Japan PMDA, China NMPA)

• 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 per sequencing strategy.

• Track approvals and coordinate product launches.

• Validation checkpoint: All target market approvals obtained; registration database updated; launch dates confirmed.

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

See: references/global-regulatory-pathways.md

Regulatory Intelligence Workflow

The agent monitors and responds to regulatory changes affecting the product portfolio.

Workflow: Regulatory Change Management

• Monitor regulatory sources -- FDA Federal Register, EU Official Journal, MDCG guidance, Notified Body communications, industry associations (AdvaMed, MedTech Europe).

• Assess relevance to current product portfolio and pipeline.

• Evaluate impact -- timeline to compliance, resource requirements, product changes needed.

• Develop compliance action plan with owners and deadlines.

• Communicate to affected stakeholders across functions.

• Implement required changes within established timelines.

• Document compliance status for management review and audit readiness.

• Validation checkpoint: Compliance action plan approved; changes implemented on schedule; no gaps at next audit.

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

Decision Frameworks

Pathway Selection Decision Tree

Is predicate device available? | Yes-+-No | | v v Is device Is risk level substantially Low-Moderate? equivalent? | | Yes-+-No Yes-+-No | | | | v v v v De Novo PMA 510(k) Consider required De Novo or PMA

Pre-Submission Meeting Decision

Factor Schedule Pre-Sub Skip Pre-Sub

Novel Technology Yes

New Intended Use Yes

Complex Testing Yes

Uncertain Predicate Yes

Clinical Data Needed Yes

Well-established

Yes

Clear Predicate

Yes

Standard Testing

Yes

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

Tools and References

Scripts

Tool Purpose Usage

regulatory_tracker.py Track submission status and timelines python regulatory_tracker.py --help

Example: Track active submissions

python scripts/regulatory_tracker.py --status active --format markdown

Example: Check overdue submissions

python scripts/regulatory_tracker.py --overdue --notify

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

Key Performance Indicators

KPI Target Calculation

First-time approval rate

85% (Approved without major deficiency / Total submitted) x 100

On-time submission

90% (Submitted by target date / Total submissions) x 100

Review cycle compliance

95% (Responses within deadline / Total requests) x 100

Regulatory hold time <20% (Days on hold / Total review days) x 100

Related Skills

Skill Integration Point

mdr-745-specialist Detailed EU MDR technical requirements

fda-consultant-specialist FDA submission deep expertise

quality-manager-qms-iso13485 QMS for regulatory compliance

risk-management-specialist ISO 14971 risk management