Profile Summary
Dr. Stephen W.
Thirty year practicing orthopedic surgeon with strong interest in clinical research and leadership positions in multiple orthopedic societies, ...
Dr. Prabir K.
Experienced and motivated bioengineer/biotechnologist with strong background in nanobiotechnology, biosensor and point of care (POC) diagnostic...
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...
Dr. Nare S.
My science qualification is Ph.D. in pharmaceutical science. My writing qualifications: - Writing in the Sciences Certificate (Stanford Univers...
Dr. Muhammad M.
"Hello and welcome to my freelance profile! I am a scientific writer and product development specialist with several years of experience ...
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...
Madhu S.
Over 5 years’ experience in Quality and Regulatory Affairs, and technical submissions for a range of medical devices, including Orthopaedics, S...
Highly motivated Product Formulation Expert and Regulatory Affairs Expert in the following fields: Medical Devices ,Pharmaceuticals ,Dietary Su...
Dr. Hafsa I.
Medical Device Production Manager with 5 years of experience in device development - Technical file - Design File - Procurement - Technology De...
Dr. Dimitrios K.
As the medical writer and sole trader of DEKAOKTO solutions....I offer MedComms services, including publication, market research, and conference support medical writing...
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. Jean J.
I am a highly experienced ultrasound engineer with a PhD in Physics/Ultrasound Imaging. I have over 10 years of experience in the ultraso...
Dr. Sophie L.
Ph.D. level scientist with more than 18 years of experience in both academia and industry. Experience in multinational corporations, managing d...
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 ...
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
Manas K.
20+ years of planning, developing, executing, managing global strategic upstream marketing initiatives including developing roadmaps for portfo...
Anil C.
Working towards catalyzing the Strategic Development of the Clients in the regulatory, quality assurance, manufacturing process development, pr...
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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...
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Biomedical E.
I am Umair Ahmed, a seasoned Biomedical Engineer and Scientist offering over 7 years of comprehensive experience in the freelance medical devic...
Dr. Hrishikesh G.
Broad hands-on software and hardware development for medical devices such as diagnostic imaging devices (PET, MRI, X-Ray and Ultrasound), blood...
Dr. Kenneth F.
• Advanced understanding of molecular diagnostics, biotechnology, and biomedical engineering concepts, with strong organizational, leadership a...
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. SENTHILKUMAR S.
Scientific Writer with 10+ years of experience with a demonstrated history of working in the Medical Device domain, SME in Clinical Evaluations...
Dr. Dilip B.
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 ...
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.
We take several measures to help you work with full confidence and peace of mind.
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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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100% satisfaction guaranteed
You have to approve the deliverables only if quality meets your expectations. If you arn’t happy, we’ll refund your money.
Project Management
Keep track of files and conversations in the user-friendly Workspace.
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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Job Done!
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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.
