Regulatory Affairs · Director · Full-time
Director, Regulatory Affairs, IVD and Medical Devices
Lead regulatory strategy and submissions for in vitro diagnostic and medical device clients, across FDA and European pathways.
CAREERS AT HOPKINS MEDTECH
Careers in Medical Device, IVD and Digital Health
Careers at Hopkins MedTech Compliance (HMC), a medical device and IVD CRO: full-time roles in regulatory affairs, quality systems, data engineering and AI, and clinical project management, and an internship program.
Explore opportunitiesWHO WE ARE
A CRO for medical devices
and diagnostics.
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.
About usTHE WORK
Our areas
of work.
Clinical operations
Study documents, site coordination, enrollment and visit tracking.
Regulatory affairs
Submission pathways, requirements and the evidence behind FDA and EU filings.
Clinical data and biostatistics
Data review and performance measures such as sensitivity, specificity and agreement.
Quality and compliance
Procedures, audit evidence and document control.
We also run an early-stage research initiative in AI and digital health, including facial and skin image analysis.
FULL-TIME · US
Full-time
open positions.
Full-time positions with Hopkins MedTech Group LLC, in the work HMC does for medical device and in vitro diagnostic companies.
View role
Quality and Compliance · Manager · Full-time
Quality Systems Manager, Medical Device and IVD
Own HMC's quality management system and lead quality system projects for medical device and IVD clients.
Clinical Data and AI · Senior Manager · Full-time
Senior Manager, Data Engineering and AI, Clinical and Diagnostic Data
Lead the data engineering behind HMC's clinical performance studies and its AI and digital health research.
Clinical Operations · Project Manager · Full-time
Clinical Project Manager, IVD and Medical Device Studies
Run clinical performance studies for IVD and medical device sponsors from start-up to close-out.
Students and early-career candidates: see the internship program.
INTERNSHIP PROGRAM · US
Internship program
for students and early-career candidates.
Supervised project work alongside our clinical, regulatory, data and quality teams.
HOW INTERNS WORK
Project supervision
and written feedback.
Each person works with a named project lead, meets on a set weekly cadence, and receives written feedback on every deliverable. Work is evaluated on accuracy and traceability of sources, documentation quality, responsiveness to feedback, and judgment about what to escalate.
Everyone works only with data and documents they are authorized to access. Confidential and patient-related information is never uploaded to public or unapproved AI tools, and all AI-assisted work is verified before it enters a deliverable.
TERMS AND RECOGNITION
Agreements
and completion documents.
- Format
- Remote / Onsite
- Agreement
- Each internship is covered by a written agreement with Hopkins MedTech Group LLC.
- Certificate
- Interns who complete the program receive a certificate of completion on company letterhead.
- Reference
- A letter of recommendation is available on completion.
THE 12-WEEK PATHWAY
Milestones
from foundations to capstone.
A supervised pathway from CRO foundations to an audit-ready capstone. Assignments depend on active studies, authorized data access and the confirmed timeline.
Weeks 1–3 · CRO foundations and documentation discipline
Learn the IVD, clinical operations, quality and regulatory service model; review patient privacy, authorized data access and approved AI-tool boundaries; summarize one sample protocol in plain language; practice file naming, version control and source traceability. Outcome: a protocol summary, terminology guide and controlled-document practice set.
Weeks 4–6 · Study operations and evidence tracking
Organize a supervised study-document or regulatory-file structure; build a tracker for sites, visits, submissions, queries or open actions; prepare meeting minutes and a recurring status summary; complete a quality check against an approved checklist. Outcome: an audit-ready tracker with a gap list and documented follow-up actions.
Weeks 7–9 · Specialization project
Select a bounded clinical, regulatory, quality, data, writing or AI project; define evidence sources, review steps and escalation points; produce a draft work product and complete structured peer review; revise while preserving assumptions and limitations. Outcome: a reviewed specialist artifact with traceable sources and quality notes.
Weeks 10–12 · Capstone delivery and handover
Finalize the project with supervisor approval and access checks; present method, evidence, limitations and remaining risks; deliver a clean handover with file map, status and next actions; prepare a portfolio-safe summary with confidential information removed. Outcome: a final capstone package, presentation and reusable operating handover.
Internship program at a glance
Work arrangement: Remote / Onsite.
| Program detail | Arrangement |
|---|---|
| Project lead | Each intern works with a named project lead. |
| Weekly cadence | Meetings follow a set weekly cadence; each deliverable receives written feedback. |
| Written agreement | Each internship is covered by a written agreement with Hopkins MedTech Group LLC. |
| Completion certificate | Interns who complete the program receive a certificate of completion on company letterhead. |
| Reference letter | A letter of recommendation is available on completion. |
| Data and AI use | Use only authorized data and project-lead-approved AI tools. Never upload confidential or patient-related information to public or unapproved AI tools. Verify AI-assisted work before delivery. |
FIND YOUR DIRECTION
Internship positions
by track.
Explore the position descriptions below.
8 internship descriptions
Healthcare & MedTech
Clinical Research Intern, Clinical Operations & Site Coordination
Study documentation, site coordination, enrollment and visit tracking, and trial master file organization for device and IVD studies
Healthcare & MedTech
Regulatory Affairs Intern, FDA and EU Submission Support
Regulatory pathway research, predicate and comparison analysis, submission document assembly, and labeling review support for FDA and European filings
Healthcare & MedTech
Clinical Data & Biostatistics Intern, Data Review and Study Quality
Study data review, query tracking, descriptive and diagnostic performance analysis, and reproducible reporting for performance studies
Healthcare & MedTech
Quality Assurance Intern, Quality Systems & Post-Market Compliance
Standard operating procedure support, document control, audit preparation, and post-market surveillance research within a medical device quality system
AI & Digital Health
AI & Computer Vision Intern, Facial and Skin Image Analysis
Image preprocessing, face region detection and segmentation, visual feature analysis, and technical feasibility testing for an early-stage skin analysis initiative
AI & Digital Health
Data Science Intern, Dataset Curation & Model Evaluation
Dataset survey and curation, annotation schema design, evaluation framework construction, and bias and reliability analysis for health- related AI research
AI & Digital Health
Digital Health Product Intern, User Research & Prototyping
User needs research, competitive product review, report and interface prototyping, and privacy-aware experience design for an early-stage digital health concept
AI & Digital Health
Healthcare Market Research Intern, Digital Health Commercialization
Market sizing, competitor and sales-channel research, pricing and business model analysis, and commercialization pathway assessment for a digital health concept
APPLICATION INFORMATION
How to apply
for an internship.
01 / CHOOSE A ROLE
Read the position description
Pick the track and the role that fit your studies and interests.
02 / SEND YOUR APPLICATION
A CV and a short note
Email info@hopkinsmedtech.com. Name the track you want, one project from the position description you would like to work on, and why.
03 / MEET YOUR PROJECT LEAD
A conversation about the work
First-round interviews are with the project lead who would supervise your work, not with a screening panel.
Internship questions
How do I apply for an internship?
Send a CV and a short note naming the track and the project you would like to work on. A conversation with the project lead follows.
Read the application processHow is internship work supervised?
Each intern works with a named project lead. Meetings follow a set weekly cadence, and each deliverable receives written feedback.
Read the program arrangementsWhich company signs the internship agreement?
Each internship is covered by a written agreement with Hopkins MedTech Group LLC.
Read the program arrangementsWhat documents are available on completion?
Interns who complete the program receive a certificate of completion on company letterhead. A letter of recommendation is available on completion.
Read the program arrangementsWhat are the rules for using AI tools?
Use only authorized data and project-lead-approved artificial intelligence (AI) tools. Do not upload confidential or patient-related information to public or unapproved tools. Verify AI-assisted work before delivery.
Read the program arrangementsIs the work remote or on site?
The work arrangement for these internships is Remote / Onsite.
Read the program arrangementsDo I need prior experience or a medical background?
No prior clinical trial, CRO or professional internship experience is required. Each position description lists the fields of study that fit the role, and coursework, labs, personal projects and self-study all count as evidence.
Read the program arrangementsWhat will an intern actually produce?
Each position description lists example assignments, a plan for the first two weeks and the deliverables for that role. Assignments depend on active studies, authorized data access and the internship timeline.
Read the program arrangementsDo interns work with patient data?
Interns work only with data and documents they have been explicitly authorized to access. Patient-identifiable information, study data and client-confidential files are never uploaded to public or unapproved AI services.
Read the program arrangementsAre the AI and digital health projects cleared or approved products?
No. The AI and digital health initiative is early-stage research, not a cleared, approved or clinically validated product.
Read the program arrangementsWho would I meet in the first interview?
First-round interviews are with the project lead who would supervise the work, not with a screening panel.
Read the program arrangementsCONTACT HMC
