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. 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. Kurtulus G.

Expert with 10+ Years of Experience in Medical, Scientific, Technical and Regulatory 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. Dimitrios K.

Medical Writer & Market Research Consultant | Delivering Clear, Concise, Actionable Insights in Pharma & Biotech
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USD 60/hr
Ph.D.
United States

I'm a Freelance Medical Writer and Market Research Consultant. I provide Innovation Consulting, Market Research, and...Medical Communication services, including competitive intelligence, clinical trial materials, and study publications...

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USD 60/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. 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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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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Adam F.

exFDA Investigator / expert in Medical Device & Combination Product design, manufacturing, and compliance
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USD 200/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...

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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. 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
Brazil

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. Adam E.

Freelance drug and medical device Regulatory Affairs consultant | Expert in preclinical and clinical trial design
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USD 100/hr
Doctorate of Philosophy (PhD)
Australia

My research interests are in the design, development and assessment of novel drugs to prevent brain injury in infants and adults.

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USD 100/hr
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Dr. Hatem D.

Statistician and Data Analyst | Expert in Medical device ,Beauty and pharmaceutical products (Filler -Botox-PRP-etc)
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USD 250/hr
Masters of Pharmacy
United Arab Emirates

Statistician and Data Analyst | Expert in Medical device ,Beauty and pharmaceutical products (Filler -Botox- PRP -etc) , with 15+ years of expe...

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USD 250/hr
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Dr. P. S. C.

Subject Matter Expert (WHO-PQ, Medical Devices, Biologics, QA/QC, Accreditation, LIMS, QMS etc.
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USD 100/hr
PhD in Biotechnology
India

Served as WHO-PQ coordinator for Support Cell for WHO Pre-Qualification Programme for In-vitro Diagnostics. Served as Expert panel member of B...

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USD 100/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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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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Peggy G.

Senior Medical Writer at Medtronic
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USD 95/hr
Medical and Scientific Writing
United States

Having over 20-years’ experience working in nursing and public health research, I turned my focus to medical writing almost a decade ago. I ha...

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USD 95/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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Manas K.

Consult/Interim/FT: Plan, Execute: Strat Mktg, NPI/NPD, Intl Biz - Device, Diag, IVD, POC, Tele, Wearable, Cybersecurity
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USD 195/hr
Continuing Education Courses, Certificates, Training: FDA 510K, MDR; NPD, CRM, Finance; CDx, MDx, Strategy
United States

20+ years of planning, developing, executing, managing global strategic upstream marketing initiatives including developing roadmaps for portfo...

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USD 195/hr
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Obuchinezia A.

Expert Medical Writer | Medical Science Liaison | RWD/RWE and eCOA specialist
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USD 60/hr
MSc Drug Discovery and Development
United Kingdom

A dynamic and results-driven Medical Affairs Professional with extensive experience in conceptualising, developing, and managing international ...

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USD 60/hr
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Waqas A.

Regulatory Affairs / Quality Operations Professional (Pharmaceuticals) | RA Freelancer & Consultant
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USD 150/hr
Double Masters
Pakistan

PROFESSIONAL PROFILE: A Regulatory Affairs/ Quality Operations Professional with thirteen years drug development experience (Pharmaceutical), w...

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USD 150/hr
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Mariem R.

Study Start Up Specialist France | Sr CRA Medical | PMCF
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USD 100/hr
Master of Public Health
France

I have 15 years of experience in the field of Public Health and Clinical Research in several positions: coordination, monitoring, project man...

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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.