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Dr. Ahram Q.
My professional background is to technically write the Scientific content, assess the researcher in research work related to Bioinformatics and...
Dr. Kurtulus G.
I am a freelance medical, scientific, and technical writer with high-quality researches at Harvard Medical School proven by research papers pub...
I have more than 6 years experience (research and pharmaceutical industry) with a long track of success. My years as a researcher provided me ...
Dr. Nare S.
My science qualification is a Ph.D. in pharmaceutical science. My writing qualifications: - Writing in the Sciences Certificate (Stanford Unive...
Dr. Dimitrios K.
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...
Dr. Muhammad M.
Hello and welcome to my freelance profile! I am an accomplished Data-Driven Scientist with extensive expertise in comprehensive data analysis a...
Dr. Diksha V.
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...
Madhu S.
Over 7 years’ experience in Quality and Regulatory Affairs, and technical submissions for a range of medical devices, including Orthopaedics, S...
Nida A.
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...
Highly motivated Product Formulation Expert and Regulatory Affairs Expert in the following fields: Medical Devices ,Pharmaceuticals ,Dietary Su...
Adam F.
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...
César Daniel B.
- Specialist in hydrocarbon gas chromatography using Gas Chromatographs with Flame Ionization Detection (GC-FID) and with Selective Detection b...
Joshita M.
A passionate researcher, with a Master’s degree in Biomedical Engineering from Carnegie Mellon University (USA), I have 9 years of product deve...
Girish H.
An accomplished, versatile, results-oriented clinical research professional with over 16 years of experience in the Pharmaceuticals & M...
Dr. JORDANA S.
B.S. in biomedicine, M.S. in physiological sciences, and Ph.D. student in pharmaceutical sciences. I have experience in preclinical and clinica...
Dr. Alex L.
Qualifications: MBiochem Molecular and Cellular Biochemistry, Oxford University PhD Haematopoetic Stem Cell Gene Therapy, University of Manches...
Dr. Pavel O.
AI engineer. Full-stack developer. Physician. Academic.
Dr. Hatem D.
Statistician and Data Analyst | Expert in Medical device ,Beauty and pharmaceutical products (Filler -Botox- PRP -etc) , with 15+ years of expe...
Dr. P. S. C.
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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Sven A.
26 years experience in Research & Development of Medical Devices, Biotechnology, many years in basic science at KI, Charite, Cambridge, Oxf...
Dr. Ana Luiza C.
I have over 8 years of experience in Clinical Research, Regulatory Affairs and Quality Assurance of implantable and electro medical devices in ...
Sonali S.
Having experience in medical device regulatory affairs, EUMDR, USFDA 510K, ISO 14971, ISO 13485
Bina P.
Strong medical professional with experience in medical writing, clinical research, pharmaceutical drug research and article writing. Ability to...
Peggy G.
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...
Manas K.
20+ years of planning, developing, executing, managing global strategic upstream marketing initiatives including developing roadmaps for portfo...
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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Our T&C include a default confidentiality clause that protects your IP and NDA for added protection before disclosing project details.
Kolabtree ensures safety and security of your payments and personal information and project details. Kolabtree’s T&C includes a default confidentiality and NDA clause.
You will receive detailed proposals directly from Kolabtree. These proposals will include a comprehensive Statement of Work (SOW), project fees, milestones, and deadlines.
You can choose to pay either a fixed or an hourly fee based on your scope of work. Pre-pay for the next milestone. You have to approve the deliverables only if the quality meets your expectations. If you arn’t happy, we’ll refund your money.
Kolabtree will share multiple quotations for your project. You have the freedom to accept the quote that aligns with your project requirement and budget. You can get in touch with us in case you want to discuss the fee.
Our T&C include a default confidentiality clause that protects your IP and NDA for added protection.
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You have to approve the deliverables only if quality meets your expectations. If you arn’t happy, we’ll refund your money.
Project Management
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Flexible, secure payments
You can choose to pay either a fixed or an hourly fee based on your requirement.
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Hire medical device regulatory consulting freelancer$500.00
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Medical device regulatory consultants for hire$600.00
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Hiring for medical device regulatory consulting services$450.00
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Need to outsource work to medical device regulatory consultants$400.00
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Medical device regulatory specialist required for startup project$600.00
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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 40−150 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.
