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.

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. 

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.

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.

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.