- Posted 01 February 2023
- LocationSanta Ana
- Job type Permanent
- Reference78906
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Senior RA Program Lead
Job description
Senior Regulatory Affairs Manager
Introduction
A global Medical Device leader in the field of Oncology products, headquartered in Irvine, CA is actively seeking a talented and experienced Regulatory Affairs Expert in the Medical Device space.This role will offer you
- The opportunity to join a global organisation, and one of the most successful in its field
- Opportunity for growth in your career with role progression and education
- Opportunity to report in to Director Level
You will be responsible for
- Global Product Submissions (FDA 510(k), CE Marking & Others)
- Class III Medical Device PMAs
- Oversight of 30 Day Notices
- Overseeing Training & Development of new Employees
You will bring the following
- 5+ Years’ of Regulatory Affairs Experience in Medtech (ISO13485)
- Class III Medical Device Submissions Experience
- Ability to Work on Multiple Projects Simultaneously
- Experience in Big Corporates