Regulatory Submissions & Compliance Lead

Pt Brighty Global Sinergi; Bekasi; On-site; IDR 300,000,000 - 600,000,000; Full time

Job summary

Fresenius Medical Care in Indonesia is seeking a Regulatory Affairs Manager to lead regulatory submissions, prepare annual reports, and ensure compliance with registrations. You will create and maintain regulatory files to support product approvals.

The role requires collaboration with cross-functional teams to interpret authority requirements and streamline processes, contributing to safe and compliant medical products across our care platforms.

Responsibilities

• To prepare regulatory submission, annual reports and ensure the authority requirements on registrations processes and procedures. Create and maintain regulatory files.
• To ensure registered products are compliant to applicable

Skills

Regulatory submissions

Compliance

Documentation

Cross-functional collaboration

Job description

Fresenius Medical Care in Indonesia is seeking a Regulatory Affairs Manager to lead regulatory submissions, prepare annual reports, and ensure compliance with registrations. You will create and maintain regulatory files to support product approvals.

The role requires collaboration with cross-functional teams to interpret authority requirements and streamline processes, contributing to safe and compliant medical products across our care platforms.