Medical Device · FDA · EU MDR · ISO 13485

Fractional Regulatory & Quality Leadership for Medical Device Companies

Thirteen years building, leading, and rescuing FDA and EU regulatory programs — from Class II startups racing toward first clearance to Fortune 500 portfolios navigating MDR transition. Senior expertise, on demand, without the cost of a full-time hire.

Book a 30-Minute Pathway Review See Services

Past Engagements Include

Johnson & Johnson MedTech Boston Scientific ARKRAY USA Smiths Medical QRx Partners
Services

Three ways to work together

Whether you need a fast strategic read, a defined project delivered, or a senior leader embedded in your team — there's a starting point that fits where you are.

Regulatory Pathway Assessment Best entry point
$4,950 fixed fee 2–3 week turnaround

A focused, written assessment of your regulatory pathway — for founders and product leaders who need clarity before committing to a full submission program. You walk away knowing the right pathway, the realistic timeline, the likely cost, and the highest-risk gaps in your current plan.

  • Device classification and pathway analysis (510(k), De Novo, PMA, EU MDR class)
  • Predicate or comparator device review
  • Pre-submission strategy and FDA/Notified Body engagement plan
  • Risk and gap assessment of your current regulatory posture
  • Realistic timeline and budget estimate
  • Written deliverable plus 90-minute review session
Project-Based Engagements
Fixed scope, fixed fee 4 weeks – 9 months

Defined regulatory and quality projects, delivered end-to-end. Each engagement begins with a scoping phase to lock the deliverables, timeline, and price before any meter starts running. No hourly billing surprises.

  • 510(k) submission preparation and authoring
  • PMA and De Novo submissions
  • EU MDR Technical Files and Design Dossiers
  • ISO 13485:2016 QMS implementation from scratch
  • ISO 14971 Risk Management program build
  • Notified Body audit preparation and remediation
  • Internal audits and supplier audits
  • CAPA closure and audit-finding remediation
  • Design History File (DHF) construction or rebuild
  • Labeling remediation and Letter-to-File programs
Fractional Regulatory & Quality Leadership
Monthly retainer 10–30 hrs/week, 3–12 months

Embedded senior leadership for medical device companies who need experienced regulatory and quality decision-making but aren't ready to hire a full-time VP. I become the de facto Head of Regulatory or Head of Quality on your team — owning strategy, signing submissions, and building the function while you scale toward an in-house hire.

  • Regulatory and quality strategy ownership
  • Cross-functional leadership across R&D, ops, and clinical
  • Direct engagement with FDA, Notified Bodies, and auditors
  • Team coaching and process build-out
  • Executive-level reporting to your board or investors
  • Smooth handoff to your eventual full-time hire
Selected Engagements

Real work, real outcomes

A representative slice of recent and prior engagements across medical devices, IVDs, and combination products.

Johnson & Johnson MedTech
Regulatory Lead, Global Orthopaedics Special Projects

Three years as FDA and EU MDR regulatory lead for thirty supplier-transfer cost-improvement projects across the orthopaedics portfolio, contributing to multimillion-dollar annual savings. Owned regulatory impact assessments, Tech File updates, 510(k) Letters-to-File, labeling remediation, and reporting to the executive team.

American Medical Manufacturing
Fractional RA/Quality Leader · Class II Launch

Stepped into a Class II company with broken design controls, supplier quality, and risk management. Reverse-engineered the Design History File, rebuilt the QMS end-to-end, and executed every regulatory deliverable required for US market launch — on a constrained timeline with limited internal resources.

ProPlate
Fractional Quality Leader · Notified Body Audit Rescue

Brought in after the Quality Manager exited weeks before the ISO 13485 notified body audit. Closed all open prior-year CAPAs, remediated ISO 14971 gaps across the organization, executed an internal audit, built supplier quality agreements, and supported the company through the audit itself.

ARKRAY USA
Regulatory & Quality PM · Six IVD Launches

Led all regulatory and quality deliverables across six in-vitro diagnostic product launches, including innovative diabetes management systems and blood analyzers. Built the Risk Management File for each, drove ISO 13485:2016 QMS implementation across the organization, and led the validation effort for SAP Business One QMS adoption.

Worell
QMS Build · Head-to-Toe Implementation

Stood up a complete ISO 13485:2016 quality system from scratch — architecture, SOPs, design control framework, risk management process, supplier qualification, internal audit program, CAPA system, and management review — to position the organization for global market entry.

Boston Scientific
Regulatory Specialist · Global GUDID Implementation

Led the global Unique Device Identification Database (GUDID) implementation across multiple product lines. Managed regulatory submissions across regions, ensured data integrity at scale, and supported post-market regulatory activities advancing approvals and market readiness.

Connor Griggs
About

Senior expertise. Direct communication. Real ownership.

I'm Connor Griggs — Master's in Regulatory Affairs, Certified Quality Auditor, and thirteen years of in-the-weeds work across FDA and EU medical device regulation.

I started inside the FDA, supporting reviewers on 510(k) and PMA submissions during my regulatory internship. From there I went into industry — Boston Scientific, ARKRAY, Smiths Medical, and a senior regulatory lead role at Johnson & Johnson MedTech overseeing global orthopaedic supply chain projects across thirty cost-improvement initiatives.

In 2017 I founded R&Q Intelligence to bring that experience directly to medical device companies who need senior regulatory and quality leadership without the cost or commitment of a full-time executive hire. I've since built two quality systems from scratch, taken Class II products from broken design controls to launch-ready, rescued companies through notified body audits, and led submissions across the spectrum of device classes and pathways.

I work best with founders, product leaders, and Quality and Regulatory teams who value clarity, follow-through, and senior judgment delivered without bureaucracy. If that sounds like your team, let's talk.

Credentials
  • Master's Degree, Regulatory Affairs & Services St. Cloud State University
  • Certified Quality Auditor: ISO 13485:2016 American Society for Quality (ASQ)
  • ISO 13485:2016 Lead Auditor (TPECS) BSI
  • EU MDR Auditor Training (Regulation 2017/745) Oriel STAT A MATRIX
  • QMS Training: FDA QSR & ISO 13485:2016 Oriel STAT A MATRIX
  • Management Systems Auditing to ISO 13485:2016 BSI
  • Leading Management Systems Audit Teams BSI
  • Bachelor's Degree, Biomedical Science Minnesota State University, Mankato
Let's talk

Ready to discuss your regulatory pathway?

The fastest way to find out if we're a fit is a 30-minute call. We'll talk about your product, where you are in the regulatory journey, and what the path forward looks like. No pitch, no obligation — just a useful conversation about your specific situation.

Book a 30-Minute Call Email Connor

Or reach out directly: connor@regulatoryleader.com