[Women-in-biology] [job] Regulatory Affairs Manager/Director - San Diego

resumes At workwondersstaffing.net via womenbio%40net.bio.net (by resumes At workwondersstaffing.net)
Mon Jan 1 14:17:42 EST 2007

[job] Regulatory Affairs Manager/Director - San Diego

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.)

If you are interested in this position, please forward
your Word formatted resume, cover note and salary requirement to resumes At 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.

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