Profile Summary
Dr. Rodolfo B.
Medical Doctor, Public Health Medicine Specialist,CMO https://www.linkedin.com/in/rodolfo-buccico-bb412624/?locale=en_US
Dr. Anjaney K.
I conduct, write, and present primary and secondary research for diverse clients, including companies, doctors, and academic scholars. More spe...
Dr. Ágatha Cristhina F.
I am a scientist with a passion for marketing and business. I love to communicate dense technical and scientific knowledge in a clear, accessib...
Dr. Toufic A.
- Proven track record and accomplished projects and products for industrial SMEs and academic partners; - Multidisciplinary approaches using qu...
Dr. Rahmat U.
A PhD with experience in programming, software development, and teaching at the university level. My research has focused on data-driven microw...
Dr. Mark P.
PhD, postdoc, senior researcher in medical physics, imaging, radiotherapy. Extraction of attributes from real-world collected data. Medical Im...
Dr. Filonid A.
A highly driven Cardiologist with 6 years of experience in diagnosing and treating patients with acute and chronic medical conditions. Clinical...
Dr. Manarshhjot S.
Product development specialist with multiple skills including data analytics, machine learning, CAD/CAM, prediction modelling. Specialist in de...
Dr. Rita M.
I have a Ph.D. in Immunology. I studied the negative regulation of immune responses, particularly on the role of the ubiquitin-modifying enzyme...
Dr. Stephanie T.
I am a freelancer with a Bachelor Degree in European Studies from De La Salle University and I am currently earning a postgraduate degree in Me...
Dr. Vera Bin San C.
Are you looking for a medical writer who can prepare regulatory submissions for an investigational medicinal product (IMP), e.g. clinical resea...
Dr. Mohamad T.
I provide specialized consulting services to pharmaceutical and medical device companies with a focus on GMP compliance, CMC development, quali...
Dr. Chi Wut W.
Pharmacology PhD; Ongoing research on diabetes and colorectal cancer; Cell/ tissue engineering; biostatistics and bioinformatics
Dr. Pierre L.
If you are an entrepreneur/founder in health-tech, I can help you * fine tune your strategy * navigate science, engineering, quality processes ...
Dr. Mehnath S.
Currently available for consulting scientific projects- Nanobiotechnology startup strategy, nanomaterial fabrication, physio-chemical character...
Dr. Yuxi Z.
In my latest research, I've uncovered some influence factors on the foreign body reaction around implants. My previous research revolves ar...
Dr. Mark F.
Professor Mark Flynn is the Executive Director of Global Impact Cluster for Better Health Healthcare and Treatment at the University of Newcast...
Dr. Lauretta I.
I am a Freelance Data Analyst. I obtained my PharmD in 2011, concentrating in Pharmacy, with a focus on clinical pharmacy at the University of ...
Dr. David N.
Ph.D. in Electrical and Computer Engineering with concentrations in machine learning, statistical testing, and biomedical signal processing. Se...
Dr. Sheraz Hussain S.
1.Preparation of Clinical Evaluation Reports (CERs) in accordance with Medical Device Regulation (MDR) and 93/42/EEC Medical Device Directive (...
Dr. Priyanka S.
Experienced researcher, innovator/Professional (~17 years) working in the area of nano-biotechnology, healthcare, environmental and clinical di...
Dr. Rahul S.
A multidisciplinary researcher with a demonstrated history of working in the field of experimental physics, nanotechnology and biosensor device...
Dr. Ashutosh N.
Demonstrable track record for driving solutions to complex analytical problems. Possesses exceptional rigour in distilling and analysing data, ...
Dr. Alan C.
Market access for medical affairs, HEOR, payer facilitation, NICE/FDA implementation, budget impact modelling, HTA
Dr. John N.
[NOT AVAIL ATM] Medical Writer and Grant Writer for 10 years across innovation-intensive research organisations in Australia including the St V...
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 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.