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MBA Quality Management
Brazil
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USD 50/hr
I have over 8 years of experience in Clinical Research, Regulatory Affairs and Quality Assurance of implantable and electro medical devices in ...
USD 50/hr
Ph.D.
Switzerland
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USD 100/hr
Ph.D. level scientist with more than 17 years of experience in both academia and industry. Experience in multinational corporations, managing d...management, innovation management and science / medical writing (blog posts, medical writing, academic publications
USD 100/hr
PhD in Electrical Engineering
United States
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USD 100/hr
Broad hands-on software and hardware development for medical devices such as diagnostic imaging devices (PET, MRI, X-Ray and Ultrasound), blood...
USD 100/hr
MS
India
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USD 70/hr
We are a Contract Research Organization (CRO) that focuses on advanced project management, clinical operations, medical writing, statistical an...gt; Feasibility survey reports, disease demographics > Standalone QC and review of documents Publicationwriting services include: > Publication planning > Primary and secondary manuscript writing
USD 70/hr
Post Graduate Diploma in Food Safety & Quality Management
India
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USD 20/hr
Over 5 years’ experience in Quality and Regulatory Affairs, and technical submissions for a range of medical devices, including Orthopaedics, S...
USD 20/hr
M.Tech Biomedical Engineering
India
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USD 45/hr
I am a research consultant with over 10 years of consultancy experience in life science/medical management consulting industry. I am proficient...
USD 45/hr
Bachelors of Science in Biochemistry
Switzerland
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USD 200/hr
I performed inspections and premarket approvals for FDA for 7.5 years. I am now a Senior Consultant operating out of Switzerland. I operate a...
USD 200/hr
Ph.D
India
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USD 75/hr
Scientific Writer with 9+ years of experience with a demonstrated history of working in the Medical Device domain, SME in Clinical Evaluations ...
USD 75/hr
Doctor of Philosophy (PhD) in Molecular Medicine
Malaysia
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USD 50/hr
1. Preparation of Clinical Evaluation Reports (CERs) in accordance with Medical Device Regulation (MDR) and 93/42/EEC Medical Device Directive ...
USD 50/hr
Ph.D. Biotechnology
United States
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USD 100/hr
I am a freelance medical, scientific, and technical writer with high-quality researches at Harvard Medical School proven by research papers pub...
USD 100/hr
PhD
United States
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USD 75/hr
I am a freelance science and medical writer who helps medical device and pharmaceutical companies create evidence-based content for physicians,...
USD 75/hr
Master of Technology - Quality Management
India
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USD 100/hr
A seasoned professional with a decade of experience, I am a Leader and Speaker in the field of Quality Assurance & Regulatory Affairs, ...
USD 100/hr
MD
United States
Mark Luhovy, MD is a medical doctor and biomedical engineer who has dedicated 20 years to the pursuit of understanding the intersection of medi...
Masters program about drug development
Spain
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USD 55/hr
I have more than 6 years experience (research and pharmaceutical industry) with a long track of success. My years as a researcher provided me ...
USD 55/hr
MS
India
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USD 100/hr
I am a medical device executive for last 20 years and have developed two innovative products, one nanotechnology based product among that. I ha...
USD 100/hr
Master degree in Science, Technology and Health
Vietnam
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USD 60/hr
EDUCATION: - Master in Science, Technology and Health - Sorbonne Université - France - Clinical Research Associate Certificate EXPERIENC...
USD 60/hr
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MSc Pharmaceutical Chemistry
India
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USD 90/hr
Specialities - Well-versed in EU Registration procedures (DC/MR, CP and nationals). - CMC Dossier Development & writing - Regulatory St...
USD 90/hr
Applied Electronics
India
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USD 20/hr
Medical Device Regulatory Specialist with years of experience and a deep understanding of European and FDA medical device regulations. Investig...
USD 20/hr
Biochemistry
United States
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USD 100/hr
Innovative Marketing professional with an R&D and Engineering background experienced in medical devices, medical services, and corporat...
USD 100/hr
MS - Biomedical Engineering
India
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USD 20/hr
A passionate lifelong student of Biomedical sciences with a Master’s degree from Carnegie Mellon University (CMU), I have always been fascinate...
USD 20/hr
Ph.D. student
United States
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USD 180/hr
R&D executive with a Masters in Plastics Engineering and 20 years of experience in the medical device industry; worked in both large-ca...
USD 180/hr
PhD
Germany
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USD 60/hr
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...
USD 60/hr
United States
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USD 85/hr
Loren DeVito, PhD, is a science and medical writer with expertise across a wide range of therapeutic areas, including oncology, neurology, card...
USD 85/hr
Doctor of Philosophy (PhD) Haematopoetic Stem Cell Gene Therapy
United Kingdom
Qualifications: MBiochem Molecular and Cellular Biochemistry, Oxford University PhD Haematopoetic Stem Cell Gene Therapy, University of Manches...
PhD
Pakistan
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USD 75/hr
Ten + years of hands-on technical working experience in the manufacturing environment covering Metal, Textiles, Food, Auto parts, Chemical proc...
USD 75/hr
Work with medical device regulatory consultants for all aspects of regulatory compliance, including product development, technical documents, and clinical evaluation. Post your project securely and get quotes for free. Kolabtree is the world's largest platform for hiring trusted freelance 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. Sign NDAs for added protection before disclosing project details.
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Kolabtree ensures safety and security of your payments and personal information and project details. Kolabtree’s T&C includes a default confidentiality clause. You can also sign NDAs and custom agreements with freelancers for additional protection.
Post your project and receive quotes from relevant freelancers. You can also search for specific freelancers by expertise and invite them to your project. Discuss your project details with each freelancer before picking the one best expert.
We assure you of a 100% satisfaction guarantee, which means you only pay when you’re 100% satisfied with the work delivered. If you aren’t happy, we will refund 100% of your money.
You can choose to pay either a fixed or an hourly fee based on your scope of work. If you’re not sure how much your project costs, you can discuss with freelancers before arriving at a mutually agreed fee.
Kolabtree's terms and conditions prohibit freelancers from claiming ownership of intellectual property, and as a client, you are able to reinforce the message with additional communication, agreements or contracts.
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Revise FDA medical device 510(k) application$200.00
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Clinical trials for FDA-licensed medical device$2100.00
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Class I Medical Devices Clinical Evaluation Report$2000.00
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CE NB for medical devices$1500.00
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Post project (Free)
Post your project publicly for all freelancers to view and send you proposals, or interact with specific freelancers privately.
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Get bids from relevant experts. Interact freely with them before making a hire.
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Share files, make audio/video calls and collaborate with your chosen expert.
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Verify the project is complete to your satisfaction before paying the expert.
Find freelance Medical Device Regulatory Consulting experts by country
- Top Medical Device Regulatory Consulting experts in Brazil
- Top Medical Device Regulatory Consulting experts in Turkey
- Top Medical Device Regulatory Consulting experts in Malaysia
- Top Medical Device Regulatory Consulting experts in Switzerland
- Top Medical Device Regulatory Consulting experts in Italy
How to hire a medical device regulatory consultant
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 compliance consultant?
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 compliance consultant?
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.
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