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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
BioTalent Ltd are acting as an employment agency in relation to this opportunity.