Profile Summary
Dr. Girish D.
Prepare and review clinical and scientific documents that are part of regulatory submission including Clicical Study protocols, Clinical Study ...
Dr. Mohamad T.
I provide specialized consulting services to pharmaceutical and medical device companies with a focus on GMP compliance, CMC development, quali...
Dr. Gabriella G.
Goal-oriented biomedical research with more than 10 years experience and demonstrated achievement in managing clinical/translational research p...
Dr. Dayene C.
Experience with: Clinical Trials Phase I-IV, Lung Therapy and Toxicology, Respiratory Disease (including COVID-19), Cell Therapy (Stem Cells), ...
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. Sam M.
I am a Doctorate (PhD) in Pharmacy, a Certified Medical Publication Professional™ (CMPP), a certified Information Mapping Professional™ (IMP) a...
Dr. Codette P.
Codette Pharma Regulatory Analytics Pvt Ltd provides top-level global regulatory and clinical support to Life Science companies. We are experts...
Dr. Sarika P.
The RAC-qualified Pharma Professional with more than 19 years of experience in regulatory, PV, and clinical research. Hold expertise in global ...
Dr. Javier G.
I am a highly skilled medical doctor with a passion for medical research and writing....With a strong background in clinical research and an extensive publication record in indexed medical...
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. Sudhansu Sekhar S.
I have twelve years of experience in pharmaceutical analytical research. My core expertise is analytical method development by various techniqu...
Dr. Randall S.
I am an ambitious and published scientist who is experienced in many scientific disciplines including Biology, Chemistry, and Engineering. I ha...
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...
Dr. Dr. Kritee P.
I am a scientist with more than 9 years of experience in the field of chemistry for healthcare applications esp. on cancer research using molec...
Dr. Claudia M.
I am a highly proficient biomedical research scientist with over 15 years of expertise in innovative antimicrobials and antimicrobial biomateri...
• Staff Research Associate - UCSD Shiley Eye Institute (Current): Project focusing on understanding retinal ischemic diseases, specifically the...
Dr. Jessica L.
My basic research experience is in tissue engineering in the neural application. I have experience in both in vitro and in vivo experiment desi...
Dr. Maria Chiara G.
I am an eye doctor and PhD candidate. I have experience in writing scientific papers, preparing presentations and reports. I will use my experi...
Dr. Gabriela L.
I have a master's and a doctorate in Pharmacology, a post-bachelor degree in Regulatory Affairs and a bachelor's degree in Pharmacy. I ...
Dr. Maicel M.
I have experience in the preparation of analysis plan and statistical processing report. I perform statistical processing in R, SPSS, Python, E...
Dr. Leticia M.
I am a pharmacist with a PhD in chemical and bioprocess engineering, working as a bioprocess scientist. I have experience with cell culture, up...
Dr. Rony C.
I have developed the required expertise to lead several ongoing projects simultaneously in an efficient manner while maintaining meticulous att...
Dr. Gabriel G.
Dynamic and accomplished researcher with over 13 years of experience in materials science, blending academic rigor with real-world impact. My...expertise in advanced material characterization has driven innovation and resulted in numerous high-impact publications...
Executive Management |Project, Program, Portfolio Management - PMO ~ Robotics |Biotech | Pharma | Medical Devices | FDA I develop and delive...
Dr. Ntube Olive N.
* Experience in conceiving, planning, designing, executing, and troubleshooting toxicology studies using various molecular biology, biochemistr...
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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.