Connor Griggs

Editor, Regulatory News. Founder and managing principal, Regulatory Leadership Partners. Thirteen years in medical device regulatory affairs and quality — starting at the FDA.

Connor Griggs

Every story on Regulatory News carries one byline, and this is it. That is a deliberate constraint rather than a boast: a publication covering regulatory decisions should be able to tell you exactly who is accountable for what it says, and a single named editor makes that unambiguous.

Where the judgement comes from

He began in 2014 as a regulatory analyst at the U.S. Food and Drug Administration, supporting reviewers through the technical review of live 510(k) and PMA submissions — which is to say he learned how a submission is actually read before he ever wrote one.

Since then: regulatory and quality roles at Smiths Medical and Boston Scientific, where he led the implementation of FDA’s Global Unique Device Identification Database; ARKRAY USA, owning every quality and regulatory deliverable for six in-vitro diagnostic launches and an organisation-wide ISO 13485:2016 implementation; and Johnson & Johnson MedTech from 2022 to 2025 as FDA and EU MDR regulatory lead for global supply-chain projects across an orthopaedic portfolio.

He founded Regulatory Leadership Partners in 2017, which publishes Regulatory News.

Credentials

  • ASQ Certified Quality Auditor (CQA), ISO 13485:2016 — American Society for Quality, 2019
  • BSI ISO 13485:2016 Lead Auditor (TPECS) — certificate 8926021, 2020
  • EU MDR Auditor Training, Regulation (EU) 2017/745 — Oriel STAT A MATRIX, 2022
  • Master’s degree, Medical Device Regulatory Affairs and Services — St. Cloud State University
  • Bachelor’s degree, Biomedical Science — Minnesota State University, Mankato

Certification numbers and issuing bodies are listed in full, with the rest of the record, on his profile at Regulatory Leadership Partners.

What he is accountable for here

Selecting what Regulatory News covers, reviewing every story against the primary record it cites, and correcting it in public when it is wrong. How we report sets out the full process, including where automation is used and where it is not.

Contact: editor@regulatorynews.com · LinkedIn