Profile Summary
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 ...
Dr. Archana N.
I am Scientific and Medical Writer with 12+ years experience in academic research and writing. I have a Ph.D. in Genetics from one of the top t...
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 10 years’ experience in Quality and Regulatory Affairs, and technical submissions for a range of medical devices, including Orthopaedics, ...
Thomas W.
Innovative Marketing professional with an R&D and Engineering background experienced in medical devices, medical services, and corporat...
Stephane G.
R&D executive with a Masters in Plastics Engineering and 20 years of experience in the medical device industry; worked in both large-ca...
Rudra P.
We are a Contract Research Organization (CRO) that focuses on advanced project management, clinical operations, medical writing, statistical an...
Dr. Alex L.
Qualifications: MBiochem Molecular and Cellular Biochemistry, Oxford University PhD Haematopoetic Stem Cell Gene Therapy, University of Manches...
Dr. Oyinkansola S.
Overview: As a dedicated Medical Doctor and accomplished Research Writer, I bring a unique blend of medical expertise and writing proficiency ...
Dr. Pavan M.
I have a doctorate in Biological Sciences with expertise in lifestyle-associated metabolic complications such as obesity, diabetes, and liver ...
Dr. Adam E.
My research interests are in the design, development and assessment of novel drugs to prevent brain injury in infants and adults.
Dr. Arinzechukwu U.
I have over 10+ years experience in medical/content/copywriting and proof-reading/editing as well as over 6+ years experience in cancer researc...
Dr. Sathesh Kumar A.
Fourteen years of R&D, Regulatory and Medical writing experience in various disciplines across In-vitro diagnostics, medical device regulat...
Dr. Grace C.
1. Clinical Evaluation Report (CER) writer and authoring of Clinical Evaluation Plan (CEP) in accordance with Medical Device Regulation (MDR), ...
Dr. Sandeep P.
Ph.D. in Chemistry having a total of 14+ years of experience in the pharmaceutical industry, expertise in the regulatory intelligence of pharma...
Dr. Trinadh Venkata Satish T.
Experienced Research Scientist with a Ph.D. and over 20+ years of demonstrated history of working in the areas of Tissue Engineering, Infectiou...
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Dr. Imen F.
PHD pharmacist, with more than 5 years of experience in Quality Assurance (QA) and Regulatory Affairs (RA). My experience enables me to help yo...
Dr. Loren D.
Loren DeVito, PhD, is a science and medical writer with expertise across a wide range of therapeutic areas, including oncology, neurology, card...
Dr. Sarah C.
Consultant to the digital health & life sciences industry with a strong research background in early stage drug discovery. I have extensive...
Dr. Azza G.
Ph.D. trained clinician with expertise in bone biology, inflammation, and osseointegration. Established a career as a medical writer three year...
Dr. Waqar L.
Ten + years of hands-on technical working experience in the manufacturing environment covering Metal, Textiles, Food, Auto parts, Chemical proc...
Dr. Nitin M.
After completing MBBS from the All India Institute of Medical Sciences, New Delhi. He pursued MD in Radiodiagnosis from SMS Medical College and...
Dr. Krutika G.
Here you can find more info:https://www.krutikagohil.com/ I am an award-winning professional digital health innovator. With my well-founded s...
Dr. Hatem D.
Statistician and Data Analyst | Expert in Medical device ,Beauty and pharmaceutical products (Filler -Botox- PRP -etc) , with 15+ years of expe...
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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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.
