Medical Device Regulatory Consultants for Hire: Find MDR Consulting Services

Dr. Stephen W.

Medical Device Expert | 30 year practicing surgeon with 4 years at FDA and 2 years medical device consulting
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USD 350/hr
arthroscopy fellowship
United States

Thirty year practicing orthopedic surgeon with strong interest in clinical research and leadership positions in multiple orthopedic societies, ...

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USD 350/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 100/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 100/hr
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Dr. Kenneth F.

Scientist with 5+ years of experience in clinical research, molecular assay design & development. SAS-certif...
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USD 120/hr
PhD Biomedical Engineering
Canada

• Advanced understanding of molecular diagnostics, biotechnology, and biomedical engineering concepts, with strong organizational, leadership a...

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USD 120/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 a Ph.D. in pharmaceutical science. My writing qualifications: - Writing in the Sciences Certificate (Stanford Unive...

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USD 50/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. Muhammad M.

Being Molecular biologist, my profession, not only profession but my passion is to technically write scientific stuff.
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USD 30/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 30/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. Diksha V.

Researcher & Writer with 11+ years of experience in biotechnology, biomedical, bioinformatics and product developmen...
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USD 100/hr
PhD
India

I am a doctorate in life sciences with an experience of over 11 years in the academic and corporate sector. I have managed projects focusing o...

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USD 100/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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Madhu S.

Quality and Regulatory Affairs professional | Expert in CE marking, EU MDR 2017, FDA submissions & lead auditor ISO1...
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USD 30/hr
Advanced PG Diploma in CR & Regulatory Affairs (APGDCR-RA)
India

Over 7 years’ experience in Quality and Regulatory Affairs, and technical submissions for a range of medical devices, including Orthopaedics, S...

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USD 30/hr
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Nida A.

Experienced MDR and FDA certified CER/Technical File Writer with 7+ 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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Lisa 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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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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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. 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. 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. 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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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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Marysa M.

Medical Devices - EU MDR SME - Clinical Eval and PMCF
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USD 200/hr
MSc. Regulatory Affairs
United States

Marysa is a Medical Device Regulatory Consultant with over six years’ experience executing clinical-regulatory documentation and demonstrated k...

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USD 200/hr
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Sven A.

Bio-Research Engineer, MSc Clinical Research & Translational Medicine, RN, MSc Biostatistics
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USD 150/hr
MSc
United States

26 years experience in Research & Development of Medical Devices, Biotechnology, many years in basic science at KI, Charite, Cambridge, Oxf...

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USD 150/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. 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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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.