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.

Senior RA Program Lead