Regulatory Affairs Manager

Radix is seeking a highly talented and strategic Regulatory Affairs Program Lead on behalf of our client, a leading global medical device corporation.

If you are an experienced RA professional looking to take ownership of complex global regulatory pathways and lead impactful programs from development to market, this is your next career step!

What You’ll Do

:Develop, execute, and manage comprehensive regulatory strategies and pathways for innovative and modified medical devices

.Lead and prepare complex FDA and international regulatory submissions to ensure timely global market approvals

.Ensure the product development process and clinical studies address all regulatory frameworks and strategic business objectives

.Act as the primary interface with global regulatory authorities (FDA, DEKRA, NMPA, PMDA) and regional affiliates worldwide

.Collaborate closely with internal cross-functional leadership teams, including R&D, Clinical, and Quality

.

What We Are Looking Fo

r:Bachelor’s degree (or higher) in a relevant scientific or engineering disciplin

e.6–8 years of solid experience in Regulatory Affairs within the Medical Device industry (not pharma

).Proven expertise in handling complex regulatory pathways and international submission

s.Strong leadership, strategic thinking, and excellent communication skill

s.Ability to travel up to 10% on averag

e.

Show more

Show less