Specialist, Regulatory Postmarket Compliance at ResMed
Sydney, New South Wales, Australia -
Full Time


Start Date

Immediate

Expiry Date

04 Dec, 25

Salary

0.0

Posted On

05 Sep, 25

Experience

6 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Regulatory Affairs

Industry

Pharmaceuticals

Description

ABOUT RESMED

At ResMed, we pioneer innovative health technologies that transform millions of lives daily. From connected respiratory care to cloud-based software solutions, our devices span the globe and connect patients, providers, and data to improve healthcare outcomes. We are proud to lead in the medical device space, where quality, compliance, and patient trust are at the heart of our innovation.
Regulatory Affairs (RA) at ResMed is central to ensuring timely and compliant access to global markets. We work across more than 140 countries to deliver safe and effective innovations that improve quality of life. With global reach, deep technical knowledge, and strong regulatory partnerships, we lead with integrity and clarity to shape the future of health technology.

POSITION SUMMARY

The Specialist, Regulatory Postmarket Compliance (SRPC) provides leadership and guidance on regulatory activities that safeguard ResMed’s products once they are on the market. This role ensures compliance with global postmarket requirements by coordinating regulatory responses to field actions, preparing and managing submissions, and maintaining traceability across regulatory reports.
Working across functions and regions, the SRPC interprets evolving standards, contributes to risk assessments, and advises stakeholders on regulatory implications of emerging data and corrective actions. The role represents Regulatory Affairs in postmarket forums, supports audit readiness, and fosters alignment between RA, Quality, Clinical, and regional teams.
Through accurate reporting, proactive regulatory intelligence, and strong collaboration with internal partners and external regulators, the SRPC enables ResMed to maintain compliance, protect patient safety, and support business objectives with integrity and responsiveness.

Responsibilities

5. OTHER DUTIES AND REQUIREMENTS

  • Perform additional responsibilities as required to support RA and RPSD objectives.
  • Contribute to process improvements and special projects across Regulatory Affairs.
  • Support inspections, audits, and team collaboration activities.
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