Medical Device Regulatory Consultants for Hire: Find MDR Consulting Services

Neha S.

Freelance Regulatory assistance and medical writing assistance
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USD 25/hr
Master in pharmacology
India

Strongly reliable and focused Regulatory Affairs Specialist with great depth and breadth of experience in medical device regulation and reporti...

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USD 25/hr
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Amrita S.

Researcher in Innovative Point-of-Care Diagnostic Solutions | Expert in R&D, Product Development, and Market Strateg...
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USD 30/hr
Masters of Science
India

Entrepreneur with over 10 years of experience in the healthcare and diagnostics industry. Proven track record in leading innovative point-of-ca...

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USD 30/hr
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Dr. Hrishikesh G.

Over 30 years of experience commercializing medical devices for large, mid-size and early stage companies.
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USD 125/hr
PhD in Electrical Engineering
United States

Broad hands-on software and hardware development for medical devices such as diagnostic imaging devices (PET, MRI, X-Ray and Ultrasound), blood...

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USD 125/hr
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Dr. Prabir K.

Research Scientist with 10+ years of experience in Life science, Biotechnology and Interdisciplinary science
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USD 60/hr
Ph.D
Portugal

Experienced and motivated bioengineer/biotechnologist with strong background in nanobiotechnology, biosensor and point of care (POC) diagnostic...

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USD 60/hr
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Dr. Sergio P.

MDR Consultant / CER writer
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USD 55/hr
Masters program about drug development
Spain

I have more than 6 years experience (research and pharmaceutical industry) with a long track of success. My years as a researcher provided me ...

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USD 55/hr
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Dr. Vera M.

Clinical Research - Drug & Medical Device development and regulatory compliance (GCP/GLP/ISO 13485) - Expert Consult...
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USD 200/hr
Post-Doc
United States

Providing leadership and strategic direction in Drug/Medical Device Development and Quality assurance to meet the new Industry challenges Leade...

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USD 200/hr
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Dr. SENTHILKUMAR S.

Helping Medical Device Companies as an SME in developing CEP, CER, PMS Plan, PSUR, PMCF Plan & Report and Manusc...
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USD 75/hr
Ph.D
India

Scientific Writer with 10+ years of experience with a demonstrated history of working in the Medical Device domain, SME in Clinical Evaluations...

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USD 75/hr
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Dr. Dilip B.

Endorsed by the Royal Academy of Engineering as having exceptional Talent in Biomedical and Medical sciences
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USD 150/hr
PhD, Neuroscience
United Kingdom

I am the holder of highly prestigious Tier 1 Exceptional Talent Visa and endorsed as such by the Royal Academy of Engineering in the fields of ...

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USD 150/hr
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Dr. Archana N.

Freelance Medical Writer | specialising in drugs and devices | medical communications | CSRs, CERs, CSPs|Editing|
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USD 80/hr
PhD
Germany

I am Scientific and Medical Writer with 12+ years experience in academic research and writing. I have a Ph.D. in Genetics from one of the top t...

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USD 80/hr
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Dr. Muhammad H.

Freelance Molecular biologist and Bioinformatician. I have 5+ years of experience in technical scientific writing.
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USD 50/hr
Doctor of Philosophy
Pakistan

It's me Dr.Hamdan, professionally computational biologist. My profession, not only professionally, but my passion is to interact with globa...

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USD 50/hr
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Sundeep A.

Medical Device, IVD, QMS, CE Certificate, FDA 510(K), EU MDR, MDSAP, ISO 13485, SaMD, PMS, CER , PMCF, Risk Management
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USD 100/hr
Master of Technology - Quality Management
India

A seasoned professional with a decade of experience, I am a Leader and Speaker in the field of Quality Assurance & Regulatory Affairs, ...

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USD 100/hr
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Thomas W.

Freelance Medical Device consultant with 30+ years experience. Visit online at LifeQuestMD.com
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USD 100/hr
Biochemistry
United States

Innovative Marketing professional with an R&D and Engineering background experienced in medical devices, medical services, and corporat...

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USD 100/hr
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Joshita M.

Biomedical Engineer, CMU | Product Manager & Medical Writer | Expert in Clinical Research with 9+ years of experienc...
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USD 30/hr
MS - Biomedical Engineering
Netherlands

A passionate researcher, with a Master’s degree in Biomedical Engineering from Carnegie Mellon University (USA), I have 9 years of product deve...

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USD 30/hr
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Stephane G.

Technical innovator - Medical Device Executive - Product development expert
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USD 160/hr
Ph.D. student
United States

R&D executive with a Masters in Plastics Engineering and 20 years of experience in the medical device industry; worked in both large-ca...

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USD 160/hr
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Girish H.

Freelance Medical Writer / Regulatory Expert in Medical Device with 16+ Years of Experience (EUMDR, ISO 13485, FDA510K)
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USD 90/hr
B.Pharmacy
India

An accomplished, versatile, results-oriented clinical research professional with over 16 years of experience in the Pharmaceuticals & M...

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USD 90/hr
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Rudra P.

Group of Clinical Research Professionals (Project Manager, Biostatisticians, CRAs, Medical Writers, SAS Prgmers)
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USD 70/hr
MS
India

We are a Contract Research Organization (CRO) that focuses on advanced project management, clinical operations, medical writing, statistical an...

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USD 70/hr
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Dr. Hafsa I.

Medical Device Regulation (MDR) - BER - Technical File - CER - ISO13485 - Production manager - SOPs - Design File - GRIN
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USD 35/hr
PhD
Pakistan

Medical Device Production Manager with 5 years of experience in device development - Technical file - Design File - Procurement - Technology De...

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USD 35/hr
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Dr. Alex L.

Former academic, medical devices regulatory affairs consultant, specialising in clinical and performance evaluation.
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Doctor of Philosophy (PhD) Haematopoetic Stem Cell Gene Therapy
United Kingdom

Qualifications: MBiochem Molecular and Cellular Biochemistry, Oxford University PhD Haematopoetic Stem Cell Gene Therapy, University of Manches...

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Dr. Oyinkansola S.

Medical Doctor and Writer: Bridging Knowledge and Communication in Healthcare
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USD 40/hr
MPH
United Kingdom

Overview: As a dedicated Medical Doctor and accomplished Research Writer, I bring a unique blend of medical expertise and writing proficiency ...

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USD 40/hr
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Dr. Pavan M.

Doctorate in Life Sciencs & Indian Patent Agent
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USD 20/hr
PhD
India

I have a doctorate in Biological Sciences with expertise in lifestyle-associated metabolic complications such as obesity, diabetes, and liver ...

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USD 20/hr
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Dr. Arinzechukwu U.

Freelance Scientific Writer and Consultant with over 6+ years in cancer research
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USD 100/hr
Molecular Haematology
United Kingdom

I have over 10+ years experience in medical/content/copywriting and proof-reading/editing as well as over 6+ years experience in cancer researc...

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USD 100/hr
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Dr. Pavel O.

AI engineer. Full-stack developer. Physician. Academic.
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USD 50/hr
Doctorate
France

AI engineer. Full-stack developer. Physician. Academic.

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USD 50/hr
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Dr. Sathesh Kumar A.

Regulatory Affairs Specialist
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USD 50/hr
Ph.D
India

Fourteen years of R&D, Regulatory and Medical writing experience in various disciplines across In-vitro diagnostics, medical device regulat...

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USD 50/hr
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Dr. Grace C.

Experienced CER Writer for medical device companies
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USD 50/hr
Doctor of Philosophy (PhD) in Molecular Medicine
Malaysia

1. Clinical Evaluation Report (CER) writer and authoring of Clinical Evaluation Plan (CEP) in accordance with Medical Device Regulation (MDR), ...

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USD 50/hr
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Dr. Sandeep P.

Ph.D. in Chemistry with 14 years of experience in regulatory affairs of pharmaceutical products and medical devices
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USD 30/hr
PhD (Chemistry)
India

Ph.D. in Chemistry having a total of 14+ years of experience in the pharmaceutical industry, expertise in the regulatory intelligence of pharma...

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USD 30/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.