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Top Freelance Medical Device Regulatory Consulting Experts for Hire

Dr. Sophie Laurenson

Healthcare and Technology Innovator and Entrepreneur
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$100.00/hr
Ph.D.
Switzerland

Ph.D. level scientist with more than 17 years of experience in both academia and industry. Experience in multinational corporations, managing d...

$100.00/hr
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Dr. Raeesa Gupte

Freelance CER Writer | Science and Medical Communications Specialist | Neurospsychiatry Expert | Creative Writer
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$75.00/hr
PhD
United States

I am a freelance science and medical writer catering to a diverse audience of scientists, healthcare professionals, pharmaceutical and medical ...

$75.00/hr
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Dr. Hrishikesh Gadagkar

Over 28 years of experience commercializing medical devices for large, mid-size and early stage companies.
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$100.00/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...

$100.00/hr
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Girish Hirpara

Freelance Medical Writer / Expert in Medical Device with 13.7 Years of Experience in Clinical Research (MDR Expert)
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$50.00/hr
B.Pharmacy
India

An accomplished, versatile, results-oriented clinical research professional with over 13.7 years of experience in the Pharmaceuticals &...

$50.00/hr
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Thomas Williams

Freelance medical device and biotechnology expert
Biochemistry
United States

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

Adam Freeman

exFDA Investigator / expert in Medical Device & Combination Product design, manufacturing, and compliance
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$200.00/hr
Bachelors of Science in Biochemistry
Switzerland

I performed inspections and premarket approvals for FDA for 7.5 years. I am now a Senior Consultant operating out of Switzerland. I operate a...

$200.00/hr
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Dr. Ana Luiza Cassin Duz

Freelance Medical writer, Clinical specialist and Regulatory affairs of Medical Devices, Ph.D. Biological Sciences
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$50.00/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 ...

$50.00/hr
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Joshita Majumdar

Biomedical Engineer, CMU | Product Manager & Medical Writer | Expert in Clinical Research with 6+ years of experienc...
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$20.00/hr
MS - Biomedical Engineering
India

A passionate lifelong student of Biomedical sciences with a Master’s degree from Carnegie Mellon University (CMU), I have always been fascinate...

$20.00/hr
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Janet Kamana

Pharmacist and medical writer with over 11 years experience
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$50.00/hr
Professional Diploma in Medical Writing
Kenya

I am a pharmacist and a professional medical writer with over 11 years experience in various medical/pharmaceutical sectors including: researc...

$50.00/hr
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Dr. Archana Nagarajan

Freelance Medical Writer | specialising in medical devices | medical communications | CER writer|Editing|
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$60.00/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...

$60.00/hr
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Dr. DR. SENTHILKUMAR S

Helping Medical Device Companies as an SME in developing CEP, CER, PMS Plan, PSUR, PMCF Plan & Report and Manuscript...
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$50.00/hr
Ph.D
India

Scientific Writer with 9+ years of experience with a demonstrated history of working in the Medical Device domain, SME in Clinical Evaluations ...

$50.00/hr
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Dr. Mrudul Vekaria

Experienced medical writer/ MDR consultant
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$25.00/hr
Master of pharmacy
India

I am medical writer with more than 5 years of experience in writing regulatory and clinical research document. My expertise is development of c...

$25.00/hr
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Dr. Mary Ritchey

Experienced real-world researcher, generating evidence from clinical data for medical devices and pharmaceuticals.
PhD, Epidemiology
United States

Mary Beth Ritchey, PhD, FISPE has spent more than 15 years in government, industry, consulting, and academia in better understanding medical pr...

Dr. Grace Chia

Experienced CER Writer for medical device companies
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$50.00/hr
Doctor of Philosophy (PhD) in Molecular Medicine
Malaysia

1. Preparation of Clinical Evaluation Reports (CERs) in accordance with Medical Device Regulation (MDR) and 93/42/EEC Medical Device Directive ...

$50.00/hr
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Dr. Evita Asumugha

CER Medical Writer/Associate Project Manager
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$110.00/hr
Masters degree in Biomedical Science
United States

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

$110.00/hr
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Dr. Amin Yousefi

Head Of Regulatory Affairs at TUMS Preclinical Core Facillity
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...

Dr. Sergio Pérez, PhD

MDR Consultant / CER writer
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$55.00/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 ...

$55.00/hr
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Lini Subin

Regulatory Affairs Expert with 16 Years Experience (Regulatory and Scientific Writing Services)
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$150.00/hr
MSc Pharmaceutical Chemistry
India

Specialities - Well-versed in EU Registration procedures (DC/MR, CP and nationals). - CMC Dossier Development & writing - Regulatory St...

$150.00/hr
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Lakshman Prakash Balajepalli

experience in Lifesciences in QA, QMS, Regulatory, EU-IVDR, medical device documentation writing clinical trial reports
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$100.00/hr
M.Sc Biochemistry
India

Experience in Lifesciences industry including over 18 years’ experience in QA, QMS, Regulatory, Manufacturing, Quality Unit (Commissioning, Qua...

$100.00/hr
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QUYNH NGUYEN

Medical Writer - Medical Device Consultant - Clinical Evaluation Report - MDD/ MDR/ MEDDEV
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$60.00/hr
Master degree in Science, Technology and Health
Vietnam

EDUCATION: - Master in Science, Technology and Health - Sorbonne Université - France - Clinical Research Associate Certificate EXPERIENC...

$60.00/hr
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Denise Arrington

Experienced Medical Device Global Quality and Regulatory Professional
Bachelor's of Science and Associates of Business Administration
United States

I am an experienced Quality and Regulatory professional with over 25 years in the medical device manufacturing industry. I have worked with Cla...

Aparajit Sahai

Medical Device Development and Commercialization Expert
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$200.00/hr
Masters in Biomedical Engineering (Medical Device Commercialization Focus)
Canada

Medical Device Professional with 3+ years of experience. Author of successful 510(k) submissions, Health Canada licence submissions.

$200.00/hr
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Dr. Stephane Gobron

Technical innovator - Medical Device Executive - Product development expert
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$180.00/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...

$180.00/hr
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Dr. Loren DeVito

Medical writer/consultant
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$85.00/hr
MA, PhD
United States

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

$85.00/hr
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Dr. Alex Langford-Smith

Former academic, medical devices regulatory affairs consultant, specialising in clinical and performance evaluation.
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...

Work with medical device regulatory consultants for all aspects of regulatory compliance, including product development, technical documents, and clinical evaluation. Post your project securely and get quotes for free. Kolabtree is the world's largest platform for hiring trusted freelance scientists and consultants on demand.

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Kolabtree ensures safety and security of your payments and personal information and project details. Kolabtree’s T&C includes a default confidentiality clause. You can also sign NDAs and custom agreements with freelancers for additional protection.

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  • Revise FDA medical device 510(k) application
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  • Class I Medical Devices Clinical Evaluation Report
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How to hire a medical device regulatory consultant

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 compliance consultant?

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 compliance consultant?

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.

Related skills

Clinical Trials           FDA Submissions          Medical Device           Medical Device Regulations (MDR)           Medical Device Regulatory Consulting
Medical Sciences           Pharmaceutical Industry           Product Development           Regulatory Writing           Research & Development           Technical Writing