Regulatory Affairs Specialist

Narooma; Sydney; Ibrido; AUD 110.000 - 140.000; Tempo pieno

Vantaggi offerti da questo lavoro

Competitive salary

Flexible benefits package

Descrizione del lavoro

Medtronic in Australia is seeking a Regulatory Affairs Specialist to support regulatory submissions, licenses, and ongoing compliance for medical devices in Australia. This onsite role is based in Macquarie Park, NSW, with no travel required.

Reporting to the Senior Regulatory Affairs Manager, you will coordinate submissions, monitor regulatory changes, maintain licenses, and collaborate with cross-functional teams to ensure market access and patient safety throughout the product lifecycle.

Competenze

• Bachelor's degree with 2+ years in Regulatory Affairs in healthcare.
• Experience preparing regulatory submissions and license renewals.
• Familiarity with QARA operations and GMP knowledge.
• Proficient with Microsoft Office.

Mansioni

• Prepare and coordinate regulatory submission packages for product registrations, licensing activities, audits, and inspections.
• Compile and maintain documentation required for submissions, license renewals, and annual registrations.
• Assess regulatory requirements and recommend actions to support compliance for labeling, manufacturing, marketing, and clinical activities.
• Monitor regulatory changes and communicate potential business impacts to stakeholders.
• Maintain and improve regulatory tracking and document control systems.
• Support interactions with regulatory authorities and respond to regulatory requests as required.
• Contribute to regulatory strategies that support timely product approvals and market access.
• Collaborate with cross-functional teams to ensure regulatory compliance throughout the product lifecycle.

Conoscenze

Regulatory submissions

QARA operations

Stakeholder collaboration

MS Office

Formazione

Bachelor's degree in life sciences or related field

Strumenti

MS Office

Descrizione del lavoro

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life

The Regulatory Affairs function supports the registration, licensing, and ongoing regulatory compliance of medical devices across the Australian market. The team partners with global and local stakeholders to ensure products meet applicable regulatory requirements, maintain market access, and support patient safety throughout the product lifecycle.

This position is based in Macquarie Park, New South Wales, Australia and follows an Onsite work arrangement. No travel is required for this role.

Reporting to the Senior Regulatory Affairs Manager, the Regulatory Affairs Specialist supports regulatory activities for a portfolio of medical devices in Australia. The role is responsible for preparing regulatory submissions, maintaining licenses and registrations, monitoring regulatory requirements, and partnering with internal stakeholders to ensure ongoing compliance with applicable regulations and quality standards.

Primary Responsibilities

• Prepare and coordinate regulatory submission packages for product registrations, licensing activities, audits, and inspections.
• Compile and maintain documentation required for submissions, license renewals, and annual registrations.
• Assess regulatory requirements and recommend actions to support compliance for product labeling, manufacturing, marketing, and clinical activities.
• Monitor regulatory changes and communicate potential business impacts to relevant stakeholders.
• Maintain and improve regulatory tracking and document control systems.
• Support interactions with regulatory authorities and respond to regulatory requests as required.
• Contribute to regulatory strategies that support timely product approvals and market access.
• Collaborate with cross-functional teams to ensure regulatory compliance throughout the product lifecycle.

Required Qualifications

• Bachelor's degree and 2+ years of experience in Regulatory Affairs within the healthcare industry.
• Experience preparing and managing regulatory submissions, registrations, or license renewals.
• Working knowledge of Quality Assurance and Regulatory Affairs (QARA) operations.
• Proficiency in Microsoft Office applications.
• Experience partnering with internal and external stakeholders to achieve compliance objectives.

Preferred Qualifications

• Bachelor's degree in Medical Science, Biological Science, or a related life sciences discipline. [
• Experience with medical device product registrations and licensing activities.
• Experience working within Good Manufacturing Practice (GMP) regulated environments.
• Knowledge of Australian medical device regulatory requirements and regulatory authority interactions.
• Experience supporting regulatory activities across multiple product portfolios.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.