Top Freelance Medical Device Regulatory Consulting Experts for Hire

Ph.D.
Switzerland
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USD 200/hr

Ph.D. level scientist with more than 18 years of experience in both academia and industry. Experience in multinational corporations, managing d...

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USD 200/hr
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USD 50/hr

My science qualification is Ph.D. in pharmaceutical science. My writing qualifications: - Writing in the Sciences Certificate (Stanford Univers...

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USD 50/hr
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PhD in Electrical Engineering
United States
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USD 100/hr

Broad hands-on software and hardware development for medical devices such as diagnostic imaging devices (PET, MRI, X-Ray and Ultrasound), blood...

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USD 100/hr
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USD 60/hr

Experienced and motivated bioengineer/biotechnologist with strong background in nanobiotechnology, biosensor and point of care (POC) diagnostic...

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USD 60/hr
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Advanced PG Diploma in CR & Regulatory Affairs (APGDCR-RA)
India
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USD 30/hr

Over 5 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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Master of Technology - Quality Management
India
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USD 100/hr

A seasoned professional with a decade of experience, I am a Leader and Speaker in the field of Quality Assurance & Regulatory Affairs, ...

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USD 100/hr
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Ph.D. student
United States
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USD 160/hr

R&D executive with a Masters in Plastics Engineering and 20 years of experience in the medical device industry; worked in both large-ca...

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USD 160/hr
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Ph.D. Biotechnology
United States
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USD 150/hr

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 150/hr
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PhD Biopharmaceutics & Pharmacokinetics
Switzerland
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USD 160/hr

Accomplished pharmaceutical industry professional with strong background in clinical pharmacology and translational medicine. Experienced in he...

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USD 160/hr
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Bachelor of Dental Surgery
India
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USD 30/hr

I am Dr. Alpa Ben, a BDS graduate from India. I have been working with healthcare service industry from past 8 years and have experience in var...

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USD 30/hr
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arthroscopy fellowship
United States
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USD 350/hr

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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Ph.D.
United States
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USD 60/hr

On Kolabtree, I offer publication, grant writing, and conference support medical writing services, including conference abstracts, peer-reviewe...

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USD 60/hr
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PhD, Neuroscience
United Kingdom
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USD 150/hr

I am the holder of highly prestigious Tier 1 Exceptional Talent Visa and endorsed as such by the Royal Academy of Engineering in the fields of ...

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USD 150/hr
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PhD-Material Science
United States
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USD 100/hr

Technology focused accomplished Material Scientist with research and professional expertise in developing innovative materials solutions. As a ...

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USD 100/hr
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MBA Quality Management
Brazil
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USD 69/hr

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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MD
United States
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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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BACHELORS DEGREE
India
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USD 35/hr

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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Masters of Science
India
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USD 300/hr

* 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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BS - Molecular Biology
United States
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USD 250/hr

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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Master degree in Science, Technology and Health
Vietnam
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USD 150/hr

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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Masters in Biotech
India
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USD 60/hr

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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Master in pharmacology
India
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USD 25/hr

Strongly reliable and focused Regulatory Affairs Specialist with great depth and breadth of experience in medical device regulation and reporti...

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USD 25/hr
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Bachelor of Pharmacy (Gold Medallist)
India
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USD 20/hr

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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Environmental Enineering - M.Sc
Ireland
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USD 200/hr

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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Masters program about drug development
Spain
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USD 55/hr

I have more than 6 years experience (research and pharmaceutical industry) with a long track of success. My years as a researcher provided me ...

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USD 55/hr
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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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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