Medical Device Regulatory Consultants for Hire: Find MDR Consulting Services

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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Michael B.

MedTech Market Access Specialist. 30+ NICE approvals. Founder and CEO Device Access UK and IGES Group Company
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USD 200/hr
United Kingdom

30+ years experience in MedTech. NICE MedTech Early Technology Assessment (NICE MetaTOOL) facilitator. Proven record in getting great technolog...

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USD 200/hr
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Kripa G.

Social Development Consultant (healthcare, skilling & education), Data and Program-scale design, M&E, MIS:India ...
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USD 300/hr
MPH
India

Experienced Public Health professional with >14 years of experience across working for healthcare, skilling and educational sectors in I...

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USD 300/hr
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Biomedical E.

MEDICAL DEVICE REGULATORY CONSULTANT EU-MDR | EU IVDR | SaMD | FDA | MHRA | SFDA | Germany | 7+ years’ Experience
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USD 30/hr
MS Biomedical Engineering
Pakistan

I am Umair Ahmed, a seasoned Biomedical Engineer and Scientist offering over 7 years of comprehensive experience in the freelance medical devic...

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USD 30/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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Pragatheeshwaran N.

Four plus years of hands-on working experience in Medical device PMS complaints handling, vigilance and RPA (Uipath )
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USD 20/hr
B.E
India

Experienced in Medical device Post Market Surveillance (PMS) and process improvement. Familiarity with USFDA (21CFR Part 820, 806 and 803), QMS...

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USD 20/hr
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Hana A.

Regulatory affairs specialist with 8 years of experience in medical devices and pharma registration in ASEAN region.
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USD 50/hr
BSc in Biotechnology
Malaysia

Regulatory submission to Health Authority, GDPMD, QMS, ISO 13485, GDP, Post market surveillance and audits.

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USD 50/hr
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Laura F.

Commercial Enablement Leader | Strategic Market Analyst | Expert Launching HighSpot
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USD 190/hr
Bachelors
United States

Results-driven commercial enablement leader with 20 years of healtcare-related experience in marketing, sales, training and product management....

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USD 190/hr
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Gayathri G.

Medical Device Registration Expert globally. Local EU country listing for medical devices. EU-MDR, UK Brexit.
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USD 75/hr
MSc Biomedical Instrumentation Engineering
United Kingdom

Key areas: Medical Device Registration in all countries EU local listing UK Brexit Authorised Representative EU MDR Gap analysis and transitio...

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USD 75/hr
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Veer P.

IVD Regulatory Affairs Expert | Experience in Technical Documentation Writing for IVDR CE Projects
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USD 30/hr
Master of Pharmacy (M.Pharm) in Pharmaceutical Regulatory Affairs
India

A seasoned IVDR Regulatory Affairs Professional with hands-on experience in Technical Documentation (STED/TD) preparation, Technical file prepa...

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USD 30/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.