Profile Summary
Dr. Alpa B.
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...
Dr. Ankur P.
My expertise is development of clinical evaluation reports (CERs). This includes experience with literature searches, post-market surveillance,...
Dr. Vishal M.
Technology focused accomplished Material Scientist with research and professional expertise in developing innovative materials solutions. As a ...
Dr. Juliana D.
Team manager for RA and Quality, Regulatory Affairs: CFDA Registration experiences in Medical device field,(imported Class 3 MD includes Defibr...
Dr. Riccardo C.
Former researcher in Nanotechnology, Life Science & AI. Actually working as specialist in medical devices
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...
Dr. Amin Y.
Experienced Head Of Regulatory Affairs with a Demonstrated History of Working in the Biotechnology Industry. Skilled in Content Development, Tr...
Dr. Bogdan M.
I am an PhD Chemical engineer with proven experience in quality assurance and regulatory affairs. Currently I am the J. Manager Global Regulato...
Dr. Nadeem A.
• Cell biologist with seven years of academic scientific writing experience • MBA candidate in Medical Devices and Healthcare Management with t...
Dr. Sunday Ojochegbe O.
Dr. Okutachi is an experienced R and D Scientist in the highly regulated molecular diagnostics | IVD industry. He holds a PhD in Cancer Cell B...
Dr. Paula P.
- Degree in Pharmaceutical Sciences, Faculty of Pharmacy, University of Porto (2000) - PhD in Analytical Chemistry, Faculty of Pharmacy, Univer...
Dr. Evita A.
A clinical research scientific writer with clinical medical, CSR. and regulatory CER expertise in MEDDEV 2.7/1 rev4 documentation, EU MDR and F...
Dr. Ioannis L.
Accomplished pharmaceutical industry professional with strong background in clinical pharmacology and translational medicine. Experienced in he...
Dr. Eric L.
With a strong scientific background, I bring extensive expertise in medical device development's regulatory and quality aspects. As an acco...
Dr. Karim E.
I hold a Ph.D. in Biological Sciences from the Université Libre de Bruxelles (ULB), Belgium, specializing in gene therapy against cancer. ...
Dr. Anna T.
Biomedical engineer with 4+ years of experience in collaborative research (medical...imaging for nuclear medicine applications) and several years of strategic management of scientific publications...
Dr. Harsh V.
A competent pharma professional with experience in Scientific writing, Regulatory competitive intelligence, DRA, F&D, MSAT and QA. Experie...
Dr. Rafaella P.
A research engineer with progressive experience across nanomaterials, hybrid materials, polymers, and composites, with knowledge in additive ma...
Dr. Afsana S.
I'm Dr. Afsana Syed, Pharm.D having an overall experience of 3.5 years in Clinical Pharmacy (1 year) and medical writing (2.5 years). I'...
Dr. Derek C.
I completed my PhD in Chemical Biology and have previously worked in the medical device, pharmaceutical, and in vitro diagnostics industries.
Alexander B.
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...
Mark L.
Mark Luhovy, MD is a medical doctor and biomedical engineer who has dedicated 20 years to the pursuit of understanding the intersection of medi...
Selina B.
Medical Communications Consultant -Writing Clinical Evaluation Reports (CER) for medical device manufacturers -Preparation of clinical reports ...
Juan Manuel F.
Clinical Project Manager, Research and Development Technical Expert and University Lecturer. 9+ years in clinical research Studies: I have a b...
Sonali S.
Having experience in medical device regulatory affairs, EUMDR, USFDA 510K, ISO 14971, ISO 13485
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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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.
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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.
