Medical Device Regulatory Consultants for Hire: Find MDR Consulting Services

Dr. Derek C.

Freelance Scientific Editor | Experienced with Medical Devices, Pharmaceuticals, & in vitro Diagnostics
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USD 40/hr
Doctor of Philosophy (Ph.D)
Canada

I completed my PhD in Chemical Biology and have previously worked in the medical device, pharmaceutical, and in vitro diagnostics industries.

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USD 40/hr
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Alexander B.

Early Phase Oncology, Expert in Trial Management, Client Relations, Site Relations, 12 years experience
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USD 250/hr
BS - Molecular Biology
United States

I have 12 years experience, starting as a Lead Coordinator at a clinical research site. Worked in the CRO space in study start-up, as a CRA, Cl...

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USD 250/hr
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Mark L.

Digital Health Consultant, Medical Doctor, Biomedical Engineer, Certified PMP, Lean Six Sigma Black Belt, 12 yrs med dev
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MD
United States

Mark Luhovy, MD is a medical doctor and biomedical engineer who has dedicated 20 years to the pursuit of understanding the intersection of medi...

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Selina B.

Experienced medical writer
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USD 70/hr
Doctorate of Medicine (MD)
United States

Medical Communications Consultant -Writing Clinical Evaluation Reports (CER) for medical device manufacturers -Preparation of clinical reports ...

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USD 70/hr
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Juan Manuel F.

Clinical Project Manager, Research and Develop. Technical Expert and University Lecturer. 9+ 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. 9+ years in clinical research Studies: I have a b...

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USD 25/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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NAVEEN A.

Pharmaceutical & Medical device professional
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USD 50/hr
Masters in Biotechnology
India

Bio-pharma & Medical Device Quality Consultant having a good blend of Manufacturing, Technology & Business with in-dept...

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USD 50/hr
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AITZAZ r.

Oxford Alumnus, Biomedical Scientist, Futurist
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USD 70/hr
M.Sc (Master of Science)
Pakistan

Always, Keen On, Keep Walking, Born to Win!

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USD 70/hr
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Viqar A.

Medical Device RAQA & NPD Specialist | ISO 13485:2016 Certified Lead Auditor
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USD 50/hr
M. Tech (Nanoscience and Technology)
India

Nanotechnology and Medical Device enthusiast with experience in New Product Development, Regulatory Affairs and Quality Management System. Work...

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USD 50/hr
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Pradip F.

R & D Expert, Scientific Advisor/Strategist/consultant with >20 years of experience in Lifesciences and Healthcar...
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USD 30/hr
M.Sc.
India

I am managing R & D project for in-vitro diagnostics, in-vitro drug screening, medical device, and vaccine development. I look into all as...

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USD 30/hr
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Regulatory 1.

Medical Device and IVD Regulatory Expert
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USD 300/hr
Masters of Science
India

* Expert knowledge on Medical Device, In-vitro Directive and Medical Device regulation in India * Qualified ISO Lead auditor, accomplished more...

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USD 300/hr
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Kavita S.

Experienced Medical Device Regulatory Affairs professional
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USD 40/hr
Post Graduate Diploma in Management (PGDM)
India

We are a team of experienced regulatory compliance expertise for Medical Devices and In-Vitro diagnostic devices across all risk classes. We ha...

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USD 40/hr
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Sachin M.

Medical Device Executive/ Medical Writer/CER Writer
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USD 100/hr
MS
India

I am a medical device executive for last 20 years and have developed two innovative products, one nanotechnology based product among that. I ha...

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USD 100/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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Lakshman Prakash B.

experience in Lifesciences in QA, QMS, Regulatory, EU-IVDR, medical device documentation writing clinical trial reports
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USD 100/hr
M.Sc Biochemistry
India

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

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USD 100/hr
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Tarun S.

Clinical Evaluation Report preparation and review as per MEDDEV 2.7.1 Rev 4
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USD 60/hr
Masters in Biotech
India

Medical device professional with strong background in single use disposables, reusable medical devices(Class I, Class II and Class III) . Broad...

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USD 60/hr
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Jacqueline V.

Clinical researcher (MICR) and Medical writer skilled in Clinical Evaluations MDR IVDR, PMS(PMSR/ PSUR) and PMCF plans
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USD 120/hr
Clinical Evalutions for MDR and IVDR
United Kingdom

Registered healthcare professional with 16 years of clinical experience in academic hospitals and clinical research. Trained in Clinical Evalua...

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USD 120/hr
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Pranay V.

Research and Development | Expert in Medical Device INDUSTRY
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USD 35/hr
BACHELORS DEGREE
India

With more than 5+ years of experience in MEDICAL DEVICE industry, I have developed many devices, regulations, SOP's as per quality standard...

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USD 35/hr
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Marin L.

10 Years of experience in medical consultation& Writing | Expertise : Infection diseases, women health, ophthalmol...
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USD 150/hr
PhD
Germany

Leading medical strategy in matrix-based global environment and providing scientific and business consultation to a local and global pharmaceut...

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USD 150/hr
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Mike K.

FDA Regulatory Consultant
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USD 150/hr
Bachelor of chemistry and Biochemistry
United States

Mr. Khalil’s professional career spans over thirty (30) years of executive and entrepreneurial leadership in pharmaceutical, medical devices, n...

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USD 150/hr
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Akhthar S.

Management Consultant maximizing clients profits through VALUE SELLING
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USD 285/hr
MBA
United States

Sr. Executive & Entrepreneur with experience in Biotech, SaaS Healthcare, Medical Devices, Biomaterials- Cellulose, fibers, starch, PHA, PB...

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USD 285/hr
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Tarun P.

Regulatory Expert (Consultant) having 25 years of experience working with Pharma, CRO and Medical Device Industry
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USD 150/hr
MBA
India

Vision-driven executive with over 25 years of demonstrated leadership in the pharmaceuticals industry. Proven track record of driving bold init...

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USD 150/hr
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Sarah B.

Biostatistics consulting services & data analysis by industry experienced Biostatistician (Medical Statistician)
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USD 130/hr
Masters of Biostatistics
United Kingdom

I'm a qualified Biostatistician with several years experience in the design and analysis of clinical studies including clinical trials. Thi...

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USD 130/hr
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Jose A.

Freelance Medical Device professional with over 25 years of experience implementing QMS systems and RA compliance
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USD 175/hr
M.S Clinical Nutrition
United States

Behind every successful medical device registration, there is a team of experts working hard to ensure it meets regulatory requirements. As a Q...

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USD 175/hr
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Valter G.

Freelance medical and pharma expert translator and soon writer.
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USD 35/hr
Msc. Analytical Clinical and Forensics Toxicology
Portugal

Animal technician/caregiver in health research for 7 years. Freelance translator and proofreader since 2017. Language pairs: Portuguese<->...

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USD 35/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.