Regulatory Affairs Manager

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Building Global Oncology MedTech & LifeScience Teams Regulatory Affairs Manager – Interventional Oncology

I’m partnering with a fast-growing company in the

interventional oncology

space that’s expanding its regulatory team. We’re seeking a

Regulatory Affairs Manager

to lead global regulatory strategy and drive key submissions for a next‑generation minimally invasive oncology portfolio.

Key Responsibilities

Lead FDA (510(k) / PMA), EU MDR, and global submissions

Guide cross-functional teams through development and commercialization

Support audits, regulatory meetings, and ongoing compliance

Monitor regulatory changes and maintain documentation / labeling accuracy

What We’re Looking For

5+ years regulatory experience in

medical devices

(Class II / III preferred)

Interventional Oncology experience is a huge plus

Strong understanding of FDA, MDR, ISO 13485

Excellent communication and project management skills

Why This Role

High‑visibility position in a rapidly expanding market

Innovative pipeline, strong leadership, and room to grow

Competitive compensation and flexible work options

Please note, I anticipate a large number of applicants to this position. Should you not meet the above criteria, and have not heard from me within 14 days, please assume your application has been unsuccessful.

Seniority level : Mid‑Senior level

Employment type : Full‑time

Job function : Quality Assurance

Industries : Medical Equipment Manufacturing, Hospitals and Health Care, and Health and Human Services

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