Description
Description:A San Diego based medical device company is seeking a Principal of Regulatory Affairs Specialist. With commercial products worldwide, the Principal Specialist will be responsible in supporting 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 in theU.S., and other international markets
- Reviews labelling for all submission work of 510(K) and PMA in international territories
- Work directly 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 pertaining to the Company's products.
Qualifications:
- 4+ Years Regulatory Affairs Experience (Medical Device or IVD)
- Hands-on submissions experience with IVD or class II and III medical device company
- Experience with 510(k) and/or PMA and/or International Registrations
- Must be collaborative and creative and work well in a group atmosphere
- Must have strong communication skills, both verbally and written ability
- Bachelor's Degree (Engineering preferred)
To find out more about Real please visit www.realstaffing.com