Sr. Regulatory Affairs- Global

Company: JJ SONIK
Location: San Jose
Posted on: February 21, 2021

Job Description:

At JJ Sonik, we bring candidates and companies together with a specialization in relocation.
Top three reasons to consider relocation:
-- You can always come back home...treat it like the 4 years you should have gone to school out of state. Today, companies don't expect you to retire from the Organization. Commit to a time frame but beware- you just might like it. Experience another lifestyle.
-- Compensation- Positions that require relocation commonly pay higher than positions that can hire from a local candidate pool. You can take that compensation level with you for life.
-- It isn't really that dramatic or complicated. We are masters at making the transition seamless So, if you or someone you know has the following experience and is open to the possibility of an opportunity outside of Hayward, then please reply for confidential consideration.
We'll tell you all about the position and where it is...give us a chance to tell you what's attractive about it.
Qualifications and Duties for the Senior Regulatory Affairs Associate

• Regulatory affairs experience required (specifically with medical devices)
• 3+ years of Regulatory Affairs experience in a Life Sciences company
• Knowledge of class II and class III products important
• Experience working with countries outside of the US specifically in the APAC regions
• Must be able to contribute to the identification and gathering of necessary data, and help to ensure the data is successfully presented for the registration of products
• Skilled in identifying and relating submission/approval requirements
• Required ability to organize, review and submit regulatory submission to authorities
• Ability to assess proposed (pre)clinical/manufacturing adjustments for regulatory filing strategies
• Familiarity with negotiating/collaborating with regulatory authorities in order to insure submission approval

Keywords: JJ SONIK, San Jose , Sr. Regulatory Affairs- Global, Other , San Jose, California