Profile Summary
QUYNH N.
EDUCATION: - Master in Science, Technology and Health - Sorbonne Université - France - Clinical Research Associate Certificate EXPERIENC...
Viktoria K.
I am an independent clinical research professional with 14 years experiences in the sector. My expert area is clinical trial protocol content r...
Tamil S.
5 years experience as an Quality Assurance professional.I have a broad background, topics include: - ISO 13485:2016 - 21 CFR 820 - ISO 14971, ...
Neethu A.
Medical Device Regulatory Specialist with years of experience and a deep understanding of European and FDA medical device regulations. Investig...
Waqas A.
PROFESSIONAL PROFILE: A Regulatory Affairs/ Quality Operations Professional with thirteen years drug development experience (Pharmaceutical), w...
Alexey D.
Product Design - Design based on expertise from the manufacturing environment, we support engineering teams by providing guidance on best prac...
Andrew B.
Technical writer with 3 years’ experience executing clinical-regulatory documentation and demonstrated knowledge of EU MDR, clinical evaluation...
ADNAN A.
20 years in Medical Devices, QA. RA, Validation for all Classifications of Medical Devices. MDR. IVDR expertise, with Software as a Medical Dev...
Ninja P.
An aspirational mind whose main interest is to pursue a career and advance in Regulatory Affairs and Quality Assurance, become part of an este...
Kristen H.
As a seasoned medical technical writer and chronic illness patient advocate, I am devoted to the meticulous translation of intricate medical in...
Viky Gilles Daniel V.
Guru providing regulatory affairs services to the medical device / medtech, biotech, and pharmaceutical industries. Qualification supported by ...
Khalaf A.
With a Bachelor of Science in Chemistry from King Saud University and a proven tenure as a Quality Director at Advance Medical Company, I posse...
Dr. Loleta R.
Seasoned clinician innovator (MD, MBA) and data-driven strategist with unique healthcare and business acumen. Proficient in leading in-depth ma...
Assaf G.
Medical devices professional with more than 25 years' experience in senior management positions in early stage medical device companies. A...
Mariem R.
I have 15 years of experience in the field of Public Health and Clinical Research in several positions: coordination, monitoring, project man...
Mohan M.
Over 35 years of broad experience as Engineering professional…Medical Device Product Regulatory Requirements, Product Design, Project Managemen...
Elaine S.
Extensive experience in orthopedic biomedical research, data analysis, manuscript writing and editing, CEP/CER writing for EU MDR, and systemat...
Ranjith P.
• Prepare Technical documentation for Medical Device CE marking • Support MDR Compliance execution by reviewing/updating/creating Technical doc...
Neha S.
Strongly reliable and focused Regulatory Affairs Specialist with great depth and breadth of experience in medical device regulation and reporti...
Karthickeyan V.
I'm an Engineering graduate having around 7 yrs experience with expert knowledge in EUMDR.
Athar A.
Globally experienced Product Executive with expertise in Digital Health and IoT medical devices using AI/ML, AR and launch in global markets. I...
Chunnan C.
An experienced professional with 20 years of industrial experience in MedTech, biopharmaceutical companies and semi-governmental organizations;...
Michael L.
I am an accomplished professional with a PhD in Optoelectronics and Laser Systems, along with an Executive Certificate in Innovation Management...
Manoj Krishnaa S.
I help clients to define the medical device documents and align with Regulatory aspects. Works with small business owners and entrepreneurs. T...
Ali H.
Consulting services including application of IEC/EN 60601-1, IEC 62304, IEC 62366, ISO 14971. Project Management - Medical Devices Compliance. ...
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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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.
