Regulatory & Compliance Lead – Medical Devices

Lead Group; Sydney; Presencial; AUD 140.000 - 200.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Regulatory affairs

Medical devices

Global registrations

Regulatory strategy

Cross-functional collaboration

Descripción del empleo

Regulatory & Compliance Lead – Medical Devices

Full-time | Redfern, Sydney

Drive global regulatory compliance for Australian-developed surgical technology.

Lead Group is partnering with an innovative Australian medical device company to recruit a Regulatory & Compliance Lead.

Developing technology for orthopaedic surgery, the business offers an opportunity to work closely with engineering, quality, clinical and commercial teams across the full product lifecycle.

This hands-on role suits an experienced regulatory professional who enjoys taking ownership,

working independently and translating complex regulatory requirements into practical advice.

The opportunity

You will lead regulatory activities across Australia, the United States, Europe and other international markets, supporting product registrations, engineering changes and ongoing compliance.

Your responsibilities will include:

• 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.

About you

You will bring:

• 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.

Experience within a medical device manufacturer or legal manufacturer environment is a MUST.. Exposure to UDI requirements and global regulatory databases will also be highly regarded.

Why consider this opportunity?

• Contribute to innovative technology supporting orthopaedic surgery.
• Take ownership of a broad international regulatory remit.
• Work closely with engineering, quality and leadership teams.
• Influence compliance decisions from product development through to post‑market monitoring.