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 50/hr
PhD
Pakistan

I have 3 years of research experience in writing scientific contents i.e research articles, Synopsis, thesis/dissertation etc. I have completed...

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USD 50/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. 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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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. Diksha V.

Scientist & Writer | Expert in life science, cancer biology, drug discovery | Data science/analysis & bioinforma...
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USD 50/hr
PhD
India

I am a doctorate in life sciences with an experience of over 9 years in the academic and corporate sector. I have managed projects focusing on...

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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. 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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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. 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. 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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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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Bina P.

Medical science liaison, medical writer, medical consultant with 5+ years of experience in clinical research.
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USD 60/hr
MD
United States

Strong medical professional with experience in medical writing, clinical research, pharmaceutical drug research and article writing. Ability to...

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USD 60/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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Haralabos P.

Medical/Pharma English into Greek translator with medical background (MD, MSc, PhD, Certified Radiologist)
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USD 35/hr
Certificate in Translation
Greece

Working as a medical translator for the past 19 years (9 years full time), I have translated a wide range of biomedical documents including med...

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USD 35/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. 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. 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. 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. 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 medical devices | medical communications | CER writer|Editing|
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USD 60/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 60/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 5 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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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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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.