Medical Device Regulatory Consultants for Hire: Find MDR Consulting Services

Dr. Muhammad M.

Being Molecular biologist, my profession, not only profession but my passion is to technically write scientific stuff.
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USD 100/hr
PhD
Pakistan

"Hello and welcome to my freelance profile! I am a scientific writer and product development specialist with several years of experience ...

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USD 100/hr
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Dr. Nare S.

More than 10 years of experience as Regulatory Affairs Specialist, Medical and Scientific Writer, Clinical Trial Consult
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USD 50/hr
PhD in Pharmacy
Armenia

My science qualification is Ph.D. in pharmaceutical science. My writing qualifications: - Writing in the Sciences Certificate (Stanford Univers...

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USD 50/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. 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
India

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. Kurtulus G.

Expert with 10+ Years of Experience in Medical, Scientific and Technical Writing
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USD 150/hr
Ph.D. Biotechnology
United States

I am a freelance medical, scientific, and technical writer with high-quality researches at Harvard Medical School proven by research papers pub...

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USD 150/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. 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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Nida A.

Experienced MDD and MDR certified CER/Technical File Writer with 5+ years of experience with multinational industries
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USD 50/hr
Law (LLB Honours)
Pakistan

An experienced clinical research and medical device Technical file writer who has certified on MEDDEV 2.7/1 Rev#4 documentation, EU MDR 2017/74...

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USD 50/hr
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Elizabeth R.

REGULATORY AFFAIRS - Medical Device - Biotech - Dietary Supplement - Pharma
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USD 200/hr
Certificate of Regulatory Affairs , Dietary Supplements and NHP
Australia

Highly motivated Product Formulation Expert and Regulatory Affairs Expert in the following fields: Medical Devices ,Pharmaceuticals ,Dietary Su...

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USD 200/hr
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César Daniel B.

BSc in Chemistry | MScs Petroleum Engineering | PGCert in Research Methodology | SME in Molecular Characterization
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USD 70/hr
Heavy Crude Oil Extraction - Petroleum Engineering
Venezuela

- Specialist in hydrocarbon gas chromatography using Gas Chromatographs with Flame Ionization Detection (GC-FID) and with Selective Detection b...

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USD 70/hr
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Dr. Ahram Q.

Expert Life Science's Researcher, writer, and Consultant
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USD 50/hr
MPhil in Bioinformatics
Pakistan

My professional background is to technically write the Scientific content, assess the researcher in research work related to Bioinformatics and...

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USD 50/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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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. 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. 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. 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. 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. JORDANA S.

Ph.D. student in pharmaceutical sciences ǀ Pre-clinical/Clinical studies ǀ Innovation ǀ Entrepreneurship ǀ Biotech
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USD 10/hr
M.Sc. Physiological Sciences
Germany

B.S. in biomedicine, M.S. in physiological sciences, and Ph.D. student in pharmaceutical sciences. I have experience in preclinical and clinica...

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USD 10/hr
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Dr. Sarah C.

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

Consultant in digital health with a strong research background in early stage drug discovery. I have extensive knowledge of the digital health ...

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USD 50/hr
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Dr. Ana Luiza C.

Freelance Medical writer, Clinical specialist and Regulatory affairs of Medical Devices, Ph.D. Biological Sciences
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USD 69/hr
MBA Quality Management
Brazil

I have over 8 years of experience in Clinical Research, Regulatory Affairs and Quality Assurance of implantable and electro medical devices in ...

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USD 69/hr
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Dr. Sophie L.

Healthcare and Technology Innovator and Entrepreneur
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USD 200/hr
Ph.D.
Switzerland

Ph.D. level scientist with more than 18 years of experience in both academia and industry. Experience in multinational corporations, managing d...

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USD 200/hr
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Juan Manuel F.

Clinical Project Manager, Research and Develop. Technical Expert and University Lecturer. 7+ years in clinical research
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USD 25/hr
Master in Project Management
Spain

Clinical Project Manager, Research and Development Technical Expert and University Lecturer. 7+ years in clinical research Studies: I have a b...

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USD 25/hr
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Sonali S.

Experience in EUMDR, 510k submission, Risk management file, ISO 13485
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USD 20/hr
Bachelor of Pharmacy (Gold Medallist)
India

Having experience in medical device regulatory affairs, EUMDR, USFDA 510K, ISO 14971, ISO 13485

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USD 20/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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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.