The Founder
Connor Griggs
CQA · MSRA · Founder & Managing Principal
Thirteen years inside medical device regulatory affairs and quality systems, from the agency to industry to the consulting table. A track record spanning FDA and EU MDR submissions, quality systems built from the ground up, and programs carried from first strategy through post-market.
- 13+
- years in medical device regulatory affairs and quality
- 100+
- regulatory and quality projects led across a 13-year career
- 6
- in-vitro diagnostic launches managed end to end
- 2
- quality management systems built from scratch
- 6
- quality-system certifications from ASQ, BSI, and Oriel
The Record
Where the judgment comes from.
Every standard this firm holds traces back to a desk Connor has actually sat at: the FDA reviewer’s, the manufacturer’s, and the consultant’s. The path runs in reverse below.
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2025 – Present
Principal Regulatory & Quality Consultant
QRx Partners
Strategic regulatory consulting for medical device manufacturers: FDA and EU MDR submissions, quality systems development, and post-market compliance for QRx clients.
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2017 – Present
Founder & Managing Principal
Regulatory Leadership Partners (Formerly R&Q Intelligence LLC)
Fractional regulatory and quality leadership across device and diagnostics clients: a ground-up QMS and reverse-engineered DHF that carried a Class II product to U.S. launch, notified-body audit preparation and CAPA closure for an ISO 13485 manufacturer, a De Novo regulatory strategy delivered to FDA, two full ISO 13485 quality system builds, and down-classification strategy work.
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2022 – 2025
Regulatory Lead
Johnson & Johnson MedTech
FDA and EU MDR regulatory lead for global supply-chain projects across a diverse orthopaedic portfolio: regulatory strategy and impact assessments for 30 concurrent supplier-transfer cost-improvement projects contributing millions in savings, executed through technical file updates and 510(k) notes-to-file for Class I and II devices in the U.S. and Class I and IIa in the EU.
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2019 – 2020
Director of Business Development
Oriel STAT A MATRIX
Led sales and client relationships for regulatory, quality, auditing, and training services across the medical device industry at one of its best-known RAQA training firms.
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2017 – 2018
Regulatory & Quality Project Manager
ARKRAY USA
Owned every quality and regulatory deliverable for six in-vitro diagnostic launches, including diabetes management systems and blood analyzers: six risk management files, an organization-wide ISO 13485:2016 implementation, and the validation of quality system software adopted across every department.
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2015 – 2016
Regulatory and Quality Specialist
Boston Scientific
Led the implementation of FDA’s Global Unique Device Identification Database (GUDID) and prepared regulatory submissions across multiple regions, supporting post-market activities and approvals.
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2014 – 2015
Regulatory and Quality Specialist
Smiths Medical
Pre-market and post-market regulatory compliance for U.S. Class II and III devices, including conversion of technical files to STED format and CAPA responses.
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2014
Regulatory Analyst
U.S. Food & Drug Administration
Supported FDA reviewers through the technical review of live 510(k) and PMA submissions. Most consultants guess how a reviewer reads a file; this firm’s founder learned it at the source.
Credentials
Six certifications. Two degrees. All verifiable.
Certification numbers and issuing bodies are listed so you can check them, because that is what we would tell you to do with any consultant.
ASQ
Certified Quality Auditor (CQA), ISO 13485:2016
American Society for Quality · 2019
BSI
ISO 13485:2016 Lead Auditor (TPECS)
Certificate 8926021 · 2020
BSI
Leading Management Systems Audit Teams
British Standards Institution · 2020
BSI
Management Systems Auditing to ISO 13485:2016
British Standards Institution · 2020
Oriel STAT A MATRIX
EU MDR Auditor Training, Regulation (EU) 2017/745
Oriel STAT A MATRIX · 2022
Oriel STAT A MATRIX
QMS for Medical Devices: FDA QSR & ISO 13485:2016
Oriel STAT A MATRIX · 2022
Master’s Degree
Medical Device Regulatory Affairs and Services
St. Cloud State University · 2014–2016
Bachelor’s Degree
Biomedical Science
Minnesota State University, Mankato · 2009–2014
How He Works
The habits clients keep hiring back.
Catch it early
Issues found in week two cost hours; issues found by an auditor cost quarters. Proactive risk identification is the discipline that prevents late-stage rework and audit findings.
Systems, not silos
Design controls, risk management, supplier quality, and submissions are one system. Connecting cross-functional outputs to the QMS is how projects stay aligned, efficient, and compliant.
Own the deliverable
Every deliverable completed to standard and on time, with expectations set clearly enough that teams move faster with fewer errors. That is the whole job.
The experience above, embedded in your team.
Regulatory Leadership Partners places this caliber of regulatory and quality leadership inside life science companies. Read about the firm, see selected engagements, or start a conversation directly.