Global Regulatory & Compliance Lead - Medical Devices

Lead Group; Sydney; On-site; AUD 140,000 - 200,000; Full time

Job summary

Lead Group partners with an innovative Australian medical device company to recruit a Regulatory & Compliance Lead. The role focuses on global regulatory activities from Australia to the US and Europe, ensuring registrations, lifecycle maintenance and ongoing compliance across markets.

You will own submissions, lifecycle changes, PMS, PMCF and UDI efforts, working closely with engineering, quality and commercial teams. A strong background in ISO 13485 and EU MDR is essential.

Qualifications

• Approximately 5+ years of hands‑on Regulatory Affairs experience within medical devices.
• Strong knowledge of Australian TGA, EU MDR and US FDA requirements.
• Practical experience with regulatory submissions, technical documentation and product lifecycle maintenance.
• Experience assessing engineering changes and advising cross‑functional teams.
• A solid understanding of post‑market surveillance, vigilance and field actions.
• Working knowledge of ISO 13485 and medical device quality management systems.
• Strong communication, attention to detail and the ability to manage regulatory priorities independently.

Responsibilities

• Global submissions and registrations: Prepare and maintain regulatory submissions, product registrations, establishment registrations and device listings.
• Engineering change control: Assess product changes, determine regulatory impacts and coordinate required notifications and submissions.
• Post-market surveillance and vigilance: Manage PMS plans, PSURs, reportability assessments, adverse event reporting and field actions.
• Technical documentation: Maintain technical files, Essential Principles and General Safety and Performance Requirements documentation.
• UDI compliance: Maintain relevant records across EUDAMED, FDA GUDID and Australian TGA databases, as applicable.
• Regulatory engagement: Liaise with regulatory authorities, Notified Bodies, Authorised Representatives and international partners.
• Product lifecycle support: Contribute to clinical evaluation updates, PMCF activities, labelling and promotional material reviews.
• Quality and compliance: Support audits, monitor regulatory developments and assist the PRRC with relevant EU MDR obligations.

Skills

Regulatory affairs

Medical devices

Global registrations

Regulatory strategy

Cross-functional collaboration

Job description

Lead Group partners with an innovative Australian medical device company to recruit a Regulatory & Compliance Lead. The role focuses on global regulatory activities from Australia to the US and Europe, ensuring registrations, lifecycle maintenance and ongoing compliance across markets.

You will own submissions, lifecycle changes, PMS, PMCF and UDI efforts, working closely with engineering, quality and commercial teams. A strong background in ISO 13485 and EU MDR is essential.