Dr. Kurtulus G.

Expert with 10+ Years of Experience in Medical, Scientific, Technical and Regulatory Writing
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USD 100/hr
Ph.D. Biotechnology
United States

I am a freelance medical, scientific, and technical writer with high-quality researches at Harvard Medical School proven by research papers pub...see more

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USD 100/hr
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Dr. Ethan S.

Academic Research Writing ; Literature Reviews ; Meta-analysis ; Technical Writing ; Medical Writing ; Systematic Review
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USD 15/hr
Masters in International Relations
United States

With over 8 years of technical content writing experience in a broad range of domains, I am a highly experienced Content Writer. My role involv...see more

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USD 15/hr
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Dr. Dimitrios K.

Medical Writer & Market Research Consultant | Delivering Clear, Concise, Actionable Insights in Pharma & Biotech
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USD 60/hr
Ph.D.
Cyprus

I'm a Freelance Medical Writer and Market Research Consultant. I provide Innovation Consulting, Market Research, and...Medical Communication services, including competitive intelligence, clinical trial materials, and study publications...see more

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USD 60/hr
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Dr. Aafaque K.

Multi-omics |Medical Writer | Systematic Review and Meta Analysis |Proteomics| Literature review | Regulatory Compliance
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USD 70/hr
Ph.D
Canada

Welcome! I am Dr. Aafaque Khan, a seasoned scientist and dedicated researcher with a specialization in Biotechnology, Biochemistry, Genetic Eng...see more

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USD 70/hr
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Nida A.

Experienced MDR and FDA certified CER/Technical File Writer with 7+ years of experience with multinational industries
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USD 50/hr
Law (LLB Honours)
Pakistan

An experienced clinical research and medical device Technical file writer who has certified on MEDDEV 2.7/1 Rev#4 documentation, EU MDR 2017/74...see more

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USD 50/hr
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Madhu S.

Quality and Regulatory Affairs professional | Expert in CE marking, EU MDR 2017, FDA submissions & lead auditor ISO1...
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USD 40/hr
Advanced PG Diploma in CR & Regulatory Affairs (APGDCR-RA)
India

Over 10 years’ experience in Quality and Regulatory Affairs, and technical submissions for a range of medical devices, including Orthopaedics, ...see more

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USD 40/hr
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Sundeep A.

Medical Device, IVD, QMS, CE Certificate, FDA 510(K), EU MDR, MDSAP, ISO 13485, SaMD, PMS, CER , PMCF, Risk Management
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USD 100/hr
Master of Technology - Quality Management
India

A seasoned professional with a decade of experience, I am a Leader and Speaker in the field of Quality Assurance & Regulatory Affairs, ...see more

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USD 100/hr
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Girish H.

Freelance Medical Writer / Regulatory Expert in Medical Device with 16+ Years of Experience (EUMDR, ISO 13485, FDA510K)
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USD 90/hr
B.Pharmacy
India

An accomplished, versatile, results-oriented clinical research professional with over 16 years of experience in the Pharmaceuticals & M...see more

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USD 90/hr
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Dr. Nauman R.

Scientific Researcher | Professional Writer | Food Scientist
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USD 30/hr
Doctor of Philosophy (PhD)
Pakistan

I am a passionate Scientific Researcher, dedicated Professional Writer, and experienced Food Scientist with a strong academic and practical bac...see more

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USD 30/hr
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Paul S.

Data Scientist | Data Engineer | Data Analysts | Python Programmer | Scientific Editor | Medical Editor
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USD 50/hr
Professional Certificate in Data Science and Machine Learning
United Kingdom

I am a Data Scientist/Engineer with extensive experience in data science, data engineering, and AI annotation. My expertise in Python programmi...see more

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USD 50/hr
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Dr. Ana Luiza C.

Freelance Medical writer, Clinical specialist and Regulatory affairs of Medical Devices, Ph.D. Biological Sciences
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USD 69/hr
MBA Quality Management
Brazil

I have over 8 years of experience in Clinical Research, Regulatory Affairs and Quality Assurance of implantable and electro medical devices in ...see more

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USD 69/hr
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Dr. Ahram Q.

Expert Life Science's Researcher, writer, and Consultant
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USD 50/hr
MPhil in Bioinformatics
Pakistan

My professional background is to technically write the Scientific content, assess the researcher in research work related to Bioinformatics and...see more

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USD 50/hr
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Marysa M.

Medical Devices - EU MDR SME - Clinical Eval and PMCF
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USD 200/hr
MSc. Regulatory Affairs
United States

Marysa is a Medical Device Regulatory Consultant with over six years’ experience executing clinical-regulatory documentation and demonstrated k...see more

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USD 200/hr
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Lini S.

Regulatory Affairs Expert with 20 Years Experience (Regulatory and Scientific Writing Services)
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USD 90/hr
MSc Pharmaceutical Chemistry
India

Specialities - Well-versed in EU Registration procedures (DC/MR, CP and nationals). - CMC Dossier Development & writing - Regulatory St...see more

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USD 90/hr
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Dr. Hrishikesh G.

Over 30 years of experience commercializing medical devices for large, mid-size and early stage companies.
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USD 125/hr
PhD in Electrical Engineering
United States

Broad hands-on software and hardware development for medical devices such as diagnostic imaging devices (PET, MRI, X-Ray and Ultrasound), blood...see more

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USD 125/hr
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Dr. Tiago V.

An enriching journey from Academia to industry, from Infectious Diseases further to Heart Valve diseases and Hemostasis.
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PhD
Portugal

BSc in Biology and a PhD in Life Sciences - Microbiology and Infection. I have > 10 years of experience of research in Infectious Dise...see more

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Dr. SENTHILKUMAR S.

Helping Medical Device Companies as an SME in developing CEP, CER, PMS Plan, PSUR, PMCF Plan & Report and Manusc...
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USD 75/hr
Ph.D
India

Scientific Writer with 10+ years of experience with a demonstrated history of working in the Medical Device domain, SME in Clinical Evaluations...see more

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USD 75/hr
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Denise A.

Experienced Regulatory Affairs Professional
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USD 150/hr
Masters of Science
United States

Hi, I'm Denise! I'm a Regulatory Affairs Professional with over 10 years of experience and a Master's Degree in Regulatory Affairs....see more

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USD 150/hr
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Adam F.

exFDA Investigator / expert in Medical Device & Combination Product design, manufacturing, and compliance
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USD 200/hr
Bachelors of Science in Biochemistry
Switzerland

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...see more

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USD 200/hr
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Dr. Jeremy V.

Freelance scientific consultant with 9+ years of experience in biotechnology and clinical research.
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USD 50/hr
PhD
France

I am a research scientist with 9+ years of experience designing, conducting and communicating research in biotechnology and medicine. I work as...see more

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USD 50/hr
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Dr. Rahul S.

Molecular Diagnosis and NGS clinical laboratory operations CLIA, CAP and FDA regulations. Natural ingredients.
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USD 200/hr
PhD
United States

Co-Founder of RetroBioTech, a consulting firm providing CAP-CLIA assay validation, FDA filing services, Shandi Ingredients developing nutraceut...see more

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USD 200/hr
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Stephane G.

Technical innovator - Medical Device Executive - Product development expert
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USD 160/hr
Ph.D. student
United States

R&D executive with a Masters in Plastics Engineering and 20 years of experience in the medical device industry; worked in both large-ca...see more

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USD 160/hr
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Rudra P.

Group of Clinical Research Professionals (Project Manager, Biostatisticians, CRAs, Medical Writers, SAS Prgmers)
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USD 70/hr
MS
India

We are a Contract Research Organization (CRO) that focuses on advanced project management, clinical operations, medical writing, statistical an...see more

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USD 70/hr
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Dr. Adam S.

Scientist and medical writer with experience writing clinical and regulatory documents, publications,
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USD 100/hr
PhD
United States

Experienced scientific and medical writer with expertise in clinical writing (clinical trial protocol, CSR, IB, ICF) and regulatory writing (IN...see more

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USD 100/hr
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Bharti S.

Scientific & Medical writer, COVID-19 virologist, Journal manuscript writing, Editor, Research papers, clinical tria...
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USD 102/hr
Master of Public Health (M.P.H.), Fundamentals of Clinical Trials
India

A strong background in virology, medical microbiology and public health qualifies me to work on COVID-19 projects (factsheets, COVID-19 at home...see more

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USD 102/hr
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Kolabtree is the leading online marketplace for medical device regulatory writing experts. Post your project, get bids, and hire qualified medical device regulatory writing consultants quickly and easily.

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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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Who Is a Medical Device Regulatory Writing Expert?

A medical device regulatory writing expert helps businesses create the necessary documentation required in order to obtain relevant accreditation to distribute medical devices into the market. 

What Does a Medical Device Regulatory Writing Expert Do?

 A medical device regulatory writing expert is primarily involved with creating various regulatory documents and dossiers that are required to be submitted by the applicant (in this case, the medical device manufacturer) to the concerned authorities for marketing authorization.

These documents are essential in order to attest that the product meets the mandates and laws laid down by the appropriate local and international regulatory bodies. This includes procedural documents, such as preclinical and clinical studies, as well as the approval documents.

Qualifications for a Medical Device Regulatory Writing Expert

Medical device regulatory writing experts typically hold a degree in the precise field they work in, such as medical or health science. In addition, they possess a strong knowledge of regulatory affairs, and a flair for writing. 

In addition, medical device regulatory writing consultants have,

  • Strong internship or hands-on training experience in the medical device industry
  • Certifications from the likes of Regulatory Affairs Professional Society (RAPS), American Medical Writers Association (AMWA) etc
  • Ability to keep themselves updates with the latest developments in the regulatory domain
  • The writing skills required to document these rules in a clear and concise manner. 

Benefits of Hiring Freelance Medical Device Regulatory Writing Consultants

With more medical writers and scientists offering their services on-demand, there is a great opportunity for businesses to outsource their regulatory consulting needs to freelance experts.

Freelance medical device regulatory writing experts typically charge less  than full time hires, and can be collaborated with on flexible schedules. Freelance platforms usually have top medical device regulatory writers from across the globe, offering companies a chance to hire a consultant that is the right fit, without barriers such as location or paperwork.

Cost of Hiring a Medical Device Regulatory Writing Consultant

Freelance medical device regulatory writing consultants usually charge as low as $20/hour, all the way up to $175/hour, depending on expertise and experience. For projects that are more intricate and detailed, and require extensive research, writers may charge between $225-250/hour.

How to Post a Project to Hire a Medical Device Regulatory Writing Expert

Before posting a project to hire a freelance medical device regulatory writing expert, consider the following,

  • Precise nature and scope of the regulatory approval and supporting documents required
  • Length and budget of the project
  • The niche expertise you’re looking for

Now, mentioning these details in the project description will help you narrow down your search, and find experts matching the precise criteria you’re looking for. On Kolabtree, you can scout and hire freelance medical device regulatory writing experts from across the globe within 24 hours.