Job Description

As a global medtech company, we are driven by our Vision of changing the trajectory of lives for a new day and our Mission to create ingenious solutions that ignite patient turnarounds. Our relentless commitment to patients and strong legacy of innovation in healthcare are the foundation of our future. If you're looking for a new chance, a new beginning, a new trajectory, LivaNova is where your talent can truly thrive. Join our talented team members worldwide to become a pioneer of tomorrow—because at LivaNova, we don’t just treat conditions — we aspire to alter the course of lives.

Position title: Regulatory Affairs Specialist – LivaNova Australia

Reports to: Quality Engineering & Regulatory Affairs Manager – LivaNova Australia

Function: Regulatory Affairs, Commercial Quality

Location: Australia (Melbourne)

We are seeking an experienced Regulatory Affairs Specialist to manage regulatory activities for Australia and New Zealand.

This role will serve as a regulatory liaison with internal cross functions as well as the regulatory authorities in Australia and New Zealand to ensure ongoing compliance throughout the product lifecycle.

The candidate is expected to partner cross-functionally with Supply Chain, Commercial, Legal, and Global Quality functions to support product availability, customer satisfaction, and regulatory compliance.

General Responsibilities:

• Prepare, submit and manage regulatory applications to TGA, including new registrations, variations and any other related regulatory applications
• Maintain and update regulatory approvals and licenses in accordance with local regulatory changes
• Monitor, interpret and share with internal relevant stakeholders new or revised TGA / MedSafe regulations and guidance's to assess the impact on company products and processes
• Act as the regulatory point of contact with local regulatory authorities during audits, inspections and queries
• Provide strategic regulatory input during product development and localization phases
• Secure relevant licenses (e.g., environmental, telecommunications & etc) for import and sale of the devices imported by LivaNova Australia in accordance with local regulations and guidelines by other government agencies
• Perform and manage the RA impact assessment for the product registered in Australia and New Zealand.
• Support and act as a liaison between the LivaNova BU’s and the New Zealand (NZ) sponsor to register product with the Medsafe and perform any RA impact assessment for changes for products registered in the NZ
• Support the QE/RA Manager in the maintenance of the Quality Management System (QMS) of LivaNova Australia

Skills and Experience:

• Minimum 3 years of experience in regulatory affairs and quality in medical device companies
• Strong knowledge of TGA’s regulations
• Knowledge of ISO 13485 & ISO 14971 preferred
• Proven experience with TGA submissions and direct communication with regulatory authorities
• Highly organized, detail-oriented, analytical, able to multi-task, effective team player

Education:

• Bachelor’s degree or higher in life sciences, pharmacy, medical technology, biomedical engineering or a related discipline

Travel Requirements:

N/A

Welcome to impact. Welcome to innovation. Welcome to your new life.