Description
Description:A Bay Area medical device company is seeking a Principal of Regulatory Affairs Specialist. With commercial products in globally, the Principal Specialist will have responsibilities to support products in theU.S., and other international markets in accordance with regulations and provisions.
Core Responsibilities:
- Manages regulatory responsibilities associated with the development, support, and manufacturing of the Company's medical device products.
- Manages and develops regulatory strategies and plans to for timely approval of new products.
- Reviews labeling for all submission work of 510(K) and PMA
- Work closely with the management team in preparation of PMA and 510(k) submissions.
- Manages filing and submissions of 510(k), PMA and/or International registrations
- Monitors and assesses Regulatory developments related to the Company's products.
Qualifications:
- 4+ Years Regulatory Affairs Experience (Device or IVD)
- Hands-on submissions experience with IVD or class II/III medical device company
- Experience with 510(k) and/or PMA and/or International Registrations
- Must be collaborative and work well in team settings
- Must have strong communication skills, both verbally and written
- Bachelor's Degree (Engineering preferred)
To find out more about Real please visit www.realstaffing.com