Medical Device Regulatory Consultants for Hire: Find MDR Consulting Services

Dr. Imen F.

Freelance: Quality Assurance/ Regulatory Affairs specialist in Medical Devices (MD)
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USD 150/hr
Quality Expert
France

PHD pharmacist, with more than 5 years of experience in Quality Assurance (QA) and Regulatory Affairs (RA). My experience enables me to help yo...

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USD 150/hr
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Dr. Loren D.

Medical writer/consultant
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USD 85/hr
Canada

Loren DeVito, PhD, is a science and medical writer with expertise across a wide range of therapeutic areas, including oncology, neurology, card...

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USD 85/hr
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Dr. Trinadh Venkata Satish T.

Experienced research scientist keenly interested in contributing to medical devices, health care and biotech projects.
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USD 50/hr
Postdoctoral Research (Department of Molecular Cellular and Developmental Biology)
Netherlands

Experienced Research Scientist with a Ph.D. and over 20+ years of demonstrated history of working in the areas of Tissue Engineering, Infectiou...

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USD 50/hr
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Dr. Sarah C.

Consultant in Digital Health & Life Sciences | Chemist | Expert in Digital Health, Drug Discovery & Organic Che...
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USD 50/hr
PhD (Chemistry)
Indonesia

Consultant to the digital health & life sciences industry with a strong research background in early stage drug discovery. I have extensive...

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USD 50/hr
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Dr. Azza G.

Medical Regulatory Writer and Editor, Clinical Evaluation Specialist
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USD 25/hr
PhD
Germany

Ph.D. trained clinician with expertise in bone biology, inflammation, and osseointegration. Established a career as a medical writer three year...

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USD 25/hr
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Dr. Waqar L.

Auditing, Consulting, Training and Operations Management for International Standards i.e. ISO, BSCI, DIN, MDD, MDR, PPE
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USD 75/hr
PhD
Pakistan

Ten + years of hands-on technical working experience in the manufacturing environment covering Metal, Textiles, Food, Auto parts, Chemical proc...

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USD 75/hr
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Dr. Nitin M.

Scientific Advisor at Melior Life Sciences (CRO) | Consultant Radiologist | AI Research Advisor at Synapsica |
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USD 125/hr
MD
India

After completing MBBS from the All India Institute of Medical Sciences, New Delhi. He pursued MD in Radiodiagnosis from SMS Medical College and...

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USD 125/hr
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Dr. Krutika G.

CMedO| Medical Device Expert | 10+ years of experience in healthcare with clinical and usability research
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USD 200/hr
PhD Neurophysiology (Emphasis Psychology)
Germany

Here you can find more info:https://www.krutikagohil.com/ I am an award-winning professional digital health innovator. With my well-founded s...

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USD 200/hr
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Dr. Alpa B.

Medical writer with 8+ years of experience in writing CEPs, CERs, PMSRs and SSCP for Class II Medical Devices
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USD 30/hr
Bachelor of Dental Surgery
India

I am Dr. Alpa Ben, a BDS graduate from India. I have been working with healthcare service industry from past 8 years and have experience in var...

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USD 30/hr
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Dr. Ankur P.

Experienced CER Writer
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USD 85/hr
Master of Science
United States

My expertise is development of clinical evaluation reports (CERs). This includes experience with literature searches, post-market surveillance,...

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USD 85/hr
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Dr. Vishal M.

Senior Scientist ★ Technology Consultant ★ Materials/Product Development ★ Innovator-serving Space, Medical &amp...
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USD 100/hr
PhD-Material Science
United States

Technology focused accomplished Material Scientist with research and professional expertise in developing innovative materials solutions. As a ...

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USD 100/hr
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Dr. Juliana D.

China Regulatory Consultant for Medical Device
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USD 120/hr
Bachelor's degree
Hong Kong

Team manager for RA and Quality, Regulatory Affairs: CFDA Registration experiences in Medical device field,(imported Class 3 MD includes Defibr...

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USD 120/hr
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Dr. Amin Y.

Head Of Regulatory Affairs at TUMS Preclinical Core Facillity
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Doctor of Pharmacy - PharmD
Iran, Islamic Republic of

Experienced Head Of Regulatory Affairs with a Demonstrated History of Working in the Biotechnology Industry. Skilled in Content Development, Tr...

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Dr. Nadeem A.

Cell and Molecular Biologist | MBA in Medical devices and Healthcare Management | Certified in Regulatory Affairs - GxP
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USD 80/hr
The London School of Economics and Political Science (LSE)
Germany

• Cell biologist with seven years of academic scientific writing experience • MBA candidate in Medical Devices and Healthcare Management with t...

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USD 80/hr
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Dr. Bogdan M.

Global Regulatory Affairs in Medical Device industry
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USD 75/hr
Doctorate
Romania

I am an PhD Chemical engineer with proven experience in quality assurance and regulatory affairs. Currently I am the J. Manager Global Regulato...

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USD 75/hr
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Dr. Sunday Ojochegbe O.

R and D Scientist in Medical device industry | Cancer research | Process Validation | Project Management and Nonprofit...
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USD 30/hr
MBA
Luxembourg

Dr. Okutachi is an experienced R and D Scientist in the highly regulated molecular diagnostics | IVD industry. He holds a PhD in Cancer Cell B...

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USD 30/hr
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Dr. Jean J.

Freelance Senior Ultrasound Physicist, Data Scientist, Software and web developer
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USD 250/hr
PhD - Physics
France

I am a highly experienced ultrasound engineer with a PhD in Physics/Ultrasound Imaging. I have over 10 years of experience in the ultraso...

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USD 250/hr
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Dr. Paula P.

Medical Writer with 15+ years of experience in scientific writing
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USD 75/hr
PhD in Pharmaceutical Sciences
Portugal

- Degree in Pharmaceutical Sciences, Faculty of Pharmacy, University of Porto (2000) - PhD in Analytical Chemistry, Faculty of Pharmacy, Univer...

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USD 75/hr
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Dr. Eric L.

Regulatory Affairs & Quality Assurance Consultant (Medical Devices)
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USD 90/hr
Ph.D. Molecular Biology
Spain

With a strong scientific background, I bring extensive expertise in medical device development's regulatory and quality aspects. As an acco...

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USD 90/hr
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Dr. Evita A.

Medical Writer/Regulatory Affairs/Project Manager
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USD 210/hr
Masters degree in Biomedical Science
United States

A clinical research scientific writer with clinical medical, CSR. and regulatory CER expertise in MEDDEV 2.7/1 rev4 documentation, EU MDR and F...

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USD 210/hr
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Dr. Ioannis L.

Pharmaceutical Industry professional with 5+ years of experience in drug development
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USD 160/hr
PhD Biopharmaceutics & Pharmacokinetics
Switzerland

Accomplished pharmaceutical industry professional with strong background in clinical pharmacology and translational medicine. Experienced in he...

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USD 160/hr
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Dr. Derek C.

Freelance Scientific Editor | Experienced with Medical Devices, Pharmaceuticals, & in vitro Diagnostics
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USD 40/hr
Doctor of Philosophy (Ph.D)
Canada

I completed my PhD in Chemical Biology and have previously worked in the medical device, pharmaceutical, and in vitro diagnostics industries.

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USD 40/hr
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Dr. Anna T.

Process and project developer ● Design Thinking ● Healthcare
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USD 150/hr
PhD in Biomedical Sciences
Switzerland

Biomedical engineer with 4+ years of experience in collaborative research (medical...imaging for nuclear medicine applications) and several years of strategic management of scientific publications...

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USD 150/hr
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Dr. Harsh V.

Medical/Scientific/Regulatory/Newsletter/CMC/Dossier/Research/Review/Thesis/Protocol/Report/Article writing & editin...
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USD 30/hr
PhD
India

A competent pharma professional with experience in Scientific writing, Regulatory competitive intelligence, DRA, F&D, MSAT and QA. Experie...

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USD 30/hr
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Dr. Rafaella P.

10 years of progressive experience in the field of biotechnology research, scientific writing, and mentoring.
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USD 50/hr
Chemistry PhD
Brazil

A research engineer with progressive experience across nanomaterials, hybrid materials, polymers, and composites, with knowledge in additive ma...

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USD 50/hr
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Work with medical device regulatory consulting freelancers for all aspects of regulatory compliance, including product development, technical documents, and clinical evaluation. Kolabtree is the world's largest platform for hiring trusted freelance mdr scientists and consultants on demand.

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How to Hire Medical Device Regulatory Consultants

Before new medical devices can go to market, myriad regulatory requirements need to be met. Accessing expertise in medical device regulatory affairs from early in product development can save costs, time, and frustration in the long run.  

What Does a Medical Device Regulatory Consultant Do?

Experts in medical device regulatory affairs work with regulatory agencies and various in-house medical, technical, and operations professionals to ensure regulatory compliance of the new device at different stages of clinical trials (where applicable) and for market authorization. These consultants have in-depth knowledge of the requirements of the relevant regulatory agencies (e.g., FDA and EMA) and notified bodies, ISO 9001 and ISO 13485, and the requirements for certification marks such as the CE mark.

While some medical device companies will have these experts on staff, there are also consulting firms and freelance consultants who specialize in this area. Specialist FDA consultants and 510(k) consultants in the US, and MDR 2017/745 consultants and IVDR 2017/746 consultants in the EU (IVDR has replaced the IVDD 98/79/EC), assist clients with medical device regulatory consulting specific to these markets.

These experts have input all along the medical device value chain, including not only R&D, clinical trials, and regulatory submissions, but also manufacturing, marketing, distribution, reimbursement, and post-market surveillance.

Experts in medical device regulatory affairs will typically have several years of experience working for a medical device company or regulatory agency. They usually have a PharmD or MD, or a Master’s or Ph.D. degree in an allied scientific field.

Medical device regulatory affairs specialists work either as freelance consultants or for medical device or pharmaceutical companies, regulatory agencies, medical device/MedTech consulting firms, or regulatory affairs consulting firms, among others. Their job titles vary and can include Regulatory Affairs Specialist, Regulatory Writer, MDR Consultant, and Regulatory Affairs Associate. While some may be generalists, others may specialize in e.g., in vitro diagnostics or digital health solutions.

How Much Does It Cost to Hire a Freelance Medical Device Regulatory Specialist?

To hire a freelance medical device regulatory specialist, the fee generally ranges from 40150 USD per hour depending on the required skillset and the level of experience necessary.

The hourly fee can be negotiated upfront based on the estimated number of project hours, or a flat fee (for projects of a defined scope) can be discussed. If you need short-term/temporary access to these specialists, then hiring a freelance medical device regulatory consultant on our platform is a convenient and cost-effective way to harness their expertise.

How Do You Write an Effective Job Post to Hire a Medical Device Regulatory Specialist?

The best way to attract the top Kolabtree freelancers in this field is to make your project description informative. You will need to provide information on the following:

  • Skills required (e.g., expertise regarding the MDR regulatory guidelines in the EU)
  • What the project area is (e.g., expansion of the market for a new medical device)
  • What the project entails (e.g., medical device registration consulting for the EU market)
  • What the deliverables are (be specific about what you need the outputs to be)
  • Duration of the project (provide an estimate of how many hours work you will need per week/by when you need the project to be completed)
  • By when you need to hire (having more leeway on this will give you more time to choose the best expert for your needs)
  • Your budget (per hour or fixed fee)
  • If you are unsure what exactly is required, providing as much detail as possible will allow the experts to still make an informed bid for your project and suggest the best routes forward.

Our platform makes it easier than ever before to connect and collaborate with medical device regulatory compliance experts.