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Rayan T.
👩💼 I am a published scientific researcher. I currently work in academia at King's College London. My areas of expertise ar...
Soundarya P.
Handled more than 30 clinical evaluation reports end to end, starting from clinical evaluation plan, literature screening, literature summaries...
Nisha N.
• Experienced Clinical research professional, with the strong academic foundation of Graduation in Pharmacy and Post-graduation in Biochemical ...
João M.
I’m a biochemist specialized in materials science; I have over 15 years experience in a mixed context of academic and industrial environments, ...
Rob F.
Rob is a Quality System and Regulatory professional with over 20 years of experience in QMS development, deployment, and remediation in the med...
Aleksandra J.
I am a highly experienced biotechnology professional with nearly two decades of dedicated engagement in developing cancer and rare disease trea...
Nicole R.
Motivated, customer-focused Project Manager within the Cardiovascular, Metabolic and Critical Care Department who has more than 16 years of exp...
Mawaddi Q.
A clinical Evaluation specialist with clinical, research and occupational audiology background. I'm passionate in clinical research and any...
Ellen S.
A dedicated and driven professional with a diverse background in biotech and a strong foundation in project management and scientific consultin...
Prerana D.
A clinical research post-graduate having a vast knowledge over a range of Medical devices consulting services on conformation of 62304:2006 sta...
Rukmani S.
I am a biomedical research scientist and a science communicator based in Ireland with over 8 years experience writing/editing manuscripts, prep...
Asma S.
A dynamic result-oriented professional holding a noteworthy 7+ years of diversified experience in the area of Intellectual property analysis an...
Sonia M.
Sales manager with experience in claim resolution
Lorenzo V.
Experience with laparoscopic, endoscopic, drug delivery (including combo devices), orthopedic implants and instruments (hip, knee, shoulder, fo...
Steve N.
Materials scientist with specialization in plastics design, analysis, processing and longevity, particularly in medical plastics and birth cont...
Giovanni N.
Agile industrial engineer with five years of experience in medical devices manufacturing. Strong capabilities for risk management, continuous i...
Mike P.
I can execute a scientific study from start to finish: • Study design • Full-stack development of an app for the...study • IRB approval • Participant recruiting • Study administration • Data analysis • Peer-reviewed publication...
John W.
Your idea only matters if you can get it funded or commercialized. I am an experienced MedTech sales leader who's helped take a start-up fr...
James B.
I am a Quality leader with an immense passion for continuous improvement and varied, extensive experience in the realm of Post Market Surveilla...
Minh Tuan T.
Regulatory and Clinical Affairs Maintained strong customer relations, providing exceptional on-site technical, clinical, and sales support to o...
Dr Ashwani G.
A medical doctor with a Masters in Business Creation & Entrepreneurship from University of Tromso. 8+ years of experience which include...
Pharmaceutical Chemist with over 10 years of experience within diverse areas of the pharmaceutical and medical devices industries, mostly focus...
Kalidoss P.
Work experience in Medical device regulatory, cybersecurity of the medical device, clinical evaluation report analysis, risk benefit analysis.
Bárbara S.
I’m a Biomedical Engineer who developed a great interest in Data Analysis and Visualization. In the projects I’ve been working on, I’ve been es...
Baris O.
15 years of medical device experience Medical imaging, technologies Medical device business, marketing Financial literacy
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 the safety and security of your payments, personal information and project details. Kolabtree’s T&C include 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 aren'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 if 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 aren'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.