Profile Summary
Dr. Ark K.
I am a PhD-qualified molecular biologist with over 20 peer-reviewed publications and scientific books. For the past 8 years, I’ve worked in the...
Braden T.
I have 10 years of experience in research and evaluation. I co-own Final Test Health Research where we mostly support clients seeking FDA clear...
Dr. Umadevi R.
A Seasoned Medical Writer and Regulatory Affairs professional with a Ph.D. and extensive expertise in authoring high-impact clinical and regula...
Dr. Anand kumar P.
ISO 42001 ARTIFICIAL INTELLIGENCE SYSTEM IMPLEMENTATION | ISO 13485 FOR MEDICAL DEVICES | ISO27001 FOR MENTAL HEALTH PRODUCT | HIPAA GDPR COMPL...
Woodrow S.
I am a Certified Quality Engineer and ISO 13485-trained Lead Auditor with a background in biomedical engineering and hands-on experience leadin...
Deepak D.
Highly motivated Regulatory Affairs professional with strong expertise in U.S. FDA 510(k) submissions, Indian import licensing (CDSCO), ISO 134...
Sohanur R.
Pharmaceutical quality and compliance specialist with over 15 years of experience in sterile manufacturing environments. Holds a Master’s degre...
Deepa K.
I’m a passionate **Biochemistry postgraduate** with over **10 years of hands-on experience in Research & Development**, driven by a deep cu...
Henvi P.
I am a Bachelor of Pharmacy graduate and a QA Executive at a medical device company specializing in orthopedic products. With hands-on experien...
Anil I.
I am a Medical Device Quality, Regulatory, and Validation Specialist with 8+ years of experience at Philips, Johnson & Johnson, Medtronic, ...
Yanka R.
I’m a biomedical innovation professional with a background in materials engineering, medical device development, and clinical translation. As a...
Dr. Diana K.
I’m a medical doctor (OB/GYN), bioinformatics & data science graduate, and experienced medical writer with 4+ years in clinical trial suppo...
Dr. Evrim Atılay T.
Throughout my career, I have led cross-functional teams in pharmaceutical development across leading companies in Turkey. I have successfully d...
Prafullakumar P.
I am medical devices regulatory affairs professional having expertise in following points - Author, Reviewer of Global Regulatory Technical Doc...
Anjan B.
I am a biomedical engineer with a master's in nanoscience and technology, specializing in AI-based image segmentation, cancer nanomedicine,...
Mina M.
I am a materials engineer with over 8 years of experience in additive manufacturing technologies, including SLM, Lithography, and resin 3D prin...
Dr. Sevgi Ç.
14+ Years academic experience, expert in scientific writing, paraphrasing and biomedical documentation. Published author in SCI journals and b...
Dr. Patricia D.
I am a Pharmacist with a PhD in Sciences Applied to Health Products (UFF) and a Master’s degree in Pharmaceutical Sciences (UFRJ), combining ov...
Dr. Shifa J.
Regulatory Affairs and Scientific Research professional with 6+ years of combined experience in biotech, academia, and government. Skilled in r...
Karissa T.
I’m a seasoned Regulatory Affairs Consultant with over 17 years of experience supporting medical device and IVD companies in achieving global c...
Dr. Harriet K.
Regulatory writing and submissions • Regulatory Intelligence and Strategy Development • Toxicology Study Monitoring • Due Diligence and Gap Ana...
Dr. Jan S.
🚀 Your Go-To Scientific Consultant for Mission-Critical Projects 🚀 Need an expert who can not only understand complex science ...
Jarrell M.
I am a medical device consultant with 25 years of experience helping companies bring products to market. I combine strong expertise in regulato...
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Dr. Anushikha D.
I am a dentist and public health professional with a Master's in Public Health from All India Institute of Medical Sciences (AIIMS), Rishik...
Dr. S G.
Certified in Quality Management Systems as per ISO 15189 - 2012 and ISO / IEC 19011, Basics of Regulatory Medical Writing, and in Medical Devi...
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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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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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.