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Regulatory Affairs Manager
Regulatory Affairs ManagerEstablished Search • Gulshan-e-Iqbal Town, Sindh, Pakistan
Regulatory Affairs Manager

Regulatory Affairs Manager

Established Search • Gulshan-e-Iqbal Town, Sindh, Pakistan
17 hours ago
Job description

Direct message the job poster from Established Search

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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    Manager • Gulshan-e-Iqbal Town, Sindh, Pakistan

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