Vacancy caducado!
Job Description
Title: Senior Regulatory Specialist 100% Remote Education: Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. Top 3 skills/experience 1) Experience with IVDs 2) Experience writing regulatory submissions (510k or IVDR) 3) Scientific/Technical education Experience: At least 5 years of experience in a regulated industry, preferred IVD, but may consider medical devices. At least 3-4 years of experience in regulatory affairs but may consider research and development. Has experience with regulatory requirements under IVDR, MDR, FDA 510k, and/or other country registration requirements. Has experience in compile, prepare, review and submit regulatory submission to authorities. Experience with labeling regulatory requirements. Has experience working with cross functional teams.Skills:- Communicate effectively verbally and in writing
- Ability to write and edit technical documents
- Ability to work effectively in a team environment
- Ability to in fast pace environment
- Attention to detail
- Problem solving skills
Vacancy caducado!