Medical Device Regulatory Consultants for Hire: Find MDR Consulting Services

Arjun L.

Physician | Clinical & Medical Affairs | CER | Scientific Writing | Pharma labeling | Strategy | HealthTech ...
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USD 70/hr
Masters of Public Health (Epidemiology, Clinical Infectious Diseases and Global Health Majors)
India

I have a blend of experience in clinical medicine, pharmaceutical industry and medical device industry....As a medical doctor, I work on infectious diseases, pulmonary and critical care and public health....

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USD 70/hr
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Peter O.

Experienced quality assurance and regulatory affairs professional in the medical device industry.
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USD 300/hr
MS Engineering Management
United States

Product experience includes Class 1, 2 and 3 devices: external defibrillators, AEDs, infusion pumps, patient monitors, image guidance, ventilat...

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USD 300/hr
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QUYNH N.

Medical Writer - Medical Device Consultant - Clinical Evaluation Report - MDR/ Performance evaluation IVDR
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USD 150/hr
Master degree in Science, Technology and Health
Vietnam

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

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USD 150/hr
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Viktoria K.

Idependent Clinical Study Protocol Reviewer and Specialist with 14 years in depth experience in clinical research| Coach
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USD 200/hr
Environmental Enineering - M.Sc
Ireland

I am an independent clinical research professional with 14 years experiences in the sector. My expert area is clinical trial protocol content r...

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USD 200/hr
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Tamil S.

5 years experience as an Quality Assurance professional.
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USD 60/hr
Bachelors of Engineering
India

5 years experience as an Quality Assurance professional.I have a broad background, topics include: - ISO 13485:2016 - 21 CFR 820 - ISO 14971, ...

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USD 60/hr
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Neethu A.

Medical Device Regulatory Specialist - U.S. FDA, 510(k), Specialized at Polymer glove 510(k) documentation
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USD 50/hr
Applied Electronics
India

Medical Device Regulatory Specialist with years of experience and a deep understanding of European and FDA medical device regulations. Investig...

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USD 50/hr
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Alexey D.

Manufacturing Consultant Product Development - Medical Device 15+ years of experience in manufacturing engineering
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USD 95/hr
Masters of Science - Material Science
Canada

Product Design - ​Design based on expertise from the manufacturing environment, we support engineering teams by providing guidance on best prac...

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USD 95/hr
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Kristen H.

Medical Writer with 5+ years of experience in systematic literature review, marketing, medical content writing
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USD 45/hr
MA Athletic Training
United States

As a seasoned medical technical writer and chronic illness patient advocate, I am devoted to the meticulous translation of intricate medical in...

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USD 45/hr
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Andrew B.

Medical writer with 4+ years of experience in clinical evaluation
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USD 50/hr
Master of Public Health
United States

Technical writer with 3 years’ experience executing clinical-regulatory documentation and demonstrated knowledge of EU MDR, clinical evaluation...

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USD 50/hr
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ADNAN A.

QA/RA Medical Devices Expert
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USD 150/hr
BEng Hons Manufacturing Engineering
United Kingdom

20 years in Medical Devices, QA. RA, Validation for all Classifications of Medical Devices. MDR. IVDR expertise, with Software as a Medical Dev...

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USD 150/hr
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Ninja P.

Regulatory Affairs Professional (Medical Device Consultant)
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USD 39/hr
Regulatory Affairs Medical Device
Canada

An aspirational mind whose main interest is to pursue a career and advance in Regulatory Affairs and Quality Assurance, become part of an este...

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USD 39/hr
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Viky Gilles Daniel V.

Global Regulatory Affairs Consultant - FDA - Medical Device - Pharma
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USD 150/hr
Global Regulatory Affairs Certification
United States

Guru providing regulatory affairs services to the medical device / medtech, biotech, and pharmaceutical industries. Qualification supported by ...

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USD 150/hr
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Khalaf A.

QA Director & Regulatory Expert | GMP & ISO | Chemical Analysis & Process Optimization for Medical Devices |...
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USD 40/hr
BA, Chemistry
Saudi Arabia

With a Bachelor of Science in Chemistry from King Saud University and a proven tenure as a Quality Director at Advance Medical Company, I posse...

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USD 40/hr
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Dr. Loleta R.

Clinician innovator with 15+ years experience in data-driven strategy, medical diagnostics and bio-entrepreneurship
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USD 90/hr
MBA Healthcare Administration
United States

Seasoned clinician innovator (MD, MBA) and data-driven strategist with unique healthcare and business acumen. Proficient in leading in-depth ma...

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USD 90/hr
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Assaf G.

Medical devices professional with more than 25 years' experience in senior management positions.
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USD 150/hr
MSc.
Israel

Medical devices professional with more than 25 years' experience in senior management positions in early stage medical device companies. A...

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USD 150/hr
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Anil C.

Over 25 years of experience as a Medical Device Regulatory Consultant | CDSCO | USFDA 510k | EU MDR CE Marking | SFDA |
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USD 300/hr
M.Sc. Microbiology
India

Working towards catalyzing the Strategic Development of the Clients in the regulatory, quality assurance, manufacturing process development, pr...

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USD 300/hr
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Athar A.

Digital Health and Connected Devices expert in Product Design & Development, Manufacturing and Regulatory Affairs.
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USD 100/hr
MBA
United Kingdom

Globally experienced Product Executive with expertise in Digital Health and IoT medical devices using AI/ML, AR and launch in global markets. I...

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USD 100/hr
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Ranjith P.

Medical Device Regulatory (Expert in Creating Technical documentation as per MDD 93/42/EEC/MDR 2017/745, CE marking)
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USD 75/hr
Masters Degree
United Kingdom

• Prepare Technical documentation for Medical Device CE marking • Support MDR Compliance execution by reviewing/updating/creating Technical doc...

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USD 75/hr
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Elaine S.

Freelance Medical Writer | Expertise in Orthopaedic Medical Devices
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USD 50/hr
Excercise and Sport Physiology - Biomechanics
United States

Extensive experience in orthopedic biomedical research, data analysis, manuscript writing and editing, CEP/CER writing for EU MDR, and systemat...

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USD 50/hr
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Mohan M.

Expert Freelance Consultant Standards, Regulatory Affairs & QMS for Medical Device Design & Manufacture
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USD 125/hr
M.E. (Control Systems)
India

Over 35 years of broad experience as Engineering professional…Medical Device Product Regulatory Requirements, Product Design, Project Managemen...

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USD 125/hr
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Karthickeyan V.

2.3 years experience in Eumdr. As a part of MDR, I'm doing freelance work in writing CER and preparing EU Technical doc.
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USD 10/hr
BE
India

I'm an Engineering graduate having around 7 yrs experience with expert knowledge in EUMDR.

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USD 10/hr
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Chunnan C.

Passionate MedTech innovator with a startup mentality, devoted to application and clinical development of novel techs
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USD 90/hr
Life Science, B.Sc.
Germany

An experienced professional with 20 years of industrial experience in MedTech, biopharmaceutical companies and semi-governmental organizations;...

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USD 90/hr
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Michael L.

R&D Expert; Specializing in Laser Systems, IVF Microscopy, and Research Lab Digitalization
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USD 140/hr
Executive certificate in Innovation management and entrepreneurship
Germany

I am an accomplished professional with a PhD in Optoelectronics and Laser Systems, along with an Executive Certificate in Innovation Management...

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USD 140/hr
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William T.

Writer and Scientist skilled in project management, compliance, and high-throughput automation within CL3 environments.
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USD 40/hr
MSc - Infection and Immunity
United Kingdom

Experienced Technical Writer and Laboratory Scientist adept at managing and executing multifaceted projects within stringent timelines. Profici...

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USD 40/hr
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Manoj Krishnaa S.

EU MDR consultant | Medical device QA RA
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USD 8/hr
B.Tech
India

I help clients to define the medical device documents and align with Regulatory aspects. Works with small business owners and entrepreneurs. T...

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USD 8/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.