[job] Regulatory Affairs Manager/Director - San Diego
res...@workwondersstaffing.net
Our client in San Diego is looking for a Regulatory Affairs Manager / Director to join their team.
Primary responsibilities will include developing and implementing strategies for the earliest
possible approvals of regulatory submissions. This role will manage 510(k) submissions,
international submissions and registrations. Duties will include approval of labeling and
promotional materials, and writing and maintaining technical files. This role will be very involved
with new product teams and will interact with product development, manufacturing and sales &
marketing. The Regulatory Affairs Manager / Director will review product changes for regulatory
impact, evaluate impact and analyze trends of government regulatory activities. Will interact
extensively with FDA and other related agencies.
This role requires a BA/BS degree in science, engineering, or medical technology. Requires at least
10 years experience in regulatory affairs. Required experience includes strong knowledge of FDA
practices and requirements. Must be an expert data evaluator. Previous experience communicating
directly with the FDA is a must. Requires experience in an FDA-regulated industry, preferably
In-Vitro Diagnostics (IVD). The position requires excellent writing skills, strong presentation
skills (oral and PowerPoint), great communication skills and strong teaming skills. Must have prior
knowledge of clinical trials and involvement in clinical trials. Requires ISO 13485 experience.
Proficient with Microsoft Office Suite (Word, PowerPoint, Excel, etc.)
Apply:
If you are interested in this position, please forward
your Word formatted resume, cover note and salary requirement to res...@workwondersstaffing.net.
Please include the specific position to which you are applying in the subject line of your email.
This will ensure your resume is routed to the correct recruiter as quickly as possible.