Position at a glance
| Item | Details |
|---|---|
| Position | Director, Regulatory Affairs, IVD and Medical Devices |
| Function | Regulatory Affairs |
| Level | Director |
| Employment type | Full-time |
| Employer | Hopkins MedTech Group LLC, doing business as Hopkins MedTech Compliance |
About the role
The Director of Regulatory Affairs sets the regulatory strategy for the in vitro diagnostic (IVD) and medical device programs HMC supports, and is accountable for the quality of every submission that leaves the company. The work runs from the first classification question to the response to the last agency request.
This is a hands-on leadership role in a contract research organization. You will advise clients directly, review and sign off on submission content, and build the team and working methods behind it.
Responsibilities
- Define regulatory pathways for client products, including 510(k), De Novo, PMA and Emergency Use Authorization in the United States and IVDR and MDR conformity routes in the European Union.
- Lead the planning and writing of FDA Pre-Submissions, and represent clients in meetings and written exchanges with the agency.
- Own the content, structure and final review of submissions, including device descriptions, substantial equivalence arguments, analytical and clinical performance summaries, and labeling.
- Work with Clinical Operations and Biostatistics so that study designs, endpoints and sample sizes produce the evidence the chosen pathway requires.
- Lead responses to additional information requests and deficiency letters, and keep each response traceable to source data.
- Track changes in FDA guidance, the Quality Management System Regulation, IVDR transition timelines and recognized consensus standards, and turn them into clear advice for clients.
- Advise companies entering the United States or Europe for the first time on establishment registration, device listing, labeling and post-market obligations.
- Hire, develop and review the work of regulatory staff, and set the templates, review steps and quality checks the team works to.
Qualifications
- Bachelor's degree in a life science, engineering or a related field; an advanced degree is an advantage.
- At least 10 years of regulatory affairs experience in medical devices or in vitro diagnostics, including at least 4 years leading people or programs.
- A record of FDA submissions you led from strategy through clearance, authorization or approval, with direct agency interaction.
- Working knowledge of 21 CFR Parts 807, 809, 812 and 820, ISO 13485 and ISO 14971, and of the European IVDR and MDR.
- Clear, exact writing, and the judgment to tell a client what the evidence does and does not support.
Preferred experience
- Experience with molecular diagnostics, point-of-care tests, companion diagnostics or software as a medical device.
- Experience in a CRO or consulting setting with several client programs running at once.
- Regulatory Affairs Certification (RAC).
- Experience supporting companies based in China or elsewhere in Asia with US or EU market entry; Mandarin is an advantage.
About Hopkins MedTech Compliance
Hopkins MedTech Compliance is an independent contract research organization (CRO) for medical devices and in vitro diagnostics (IVD). Operated by Hopkins MedTech Group LLC, a New Jersey limited liability company, we plan and run clinical performance studies and prepare the regulatory submissions that follow, for the United States (FDA) and the European Union.
How to apply
Send your CV and a short note naming this role (HMC-FT-01) to info@hopkinsmedtech.com, or use the contact page.
