Regulatory Affairs & Quality Specialist - Medical Devices

THE COMPANY YOU WOULD BE JOINING

• In Australia, this global medical device company has been caring for patients for more than two decades.
• As a result, they intimately understand the impact the disease they focus on treating, has on people's lives.
• They are committed to providing outstanding patient care that goes beyond innovative products and therapies.

WHAT’S IN IT FOR YOU?

• A global healthcare company focusing on one very niche therapy area.
• Very successful company in their field.
• Outstanding reputation and credibility amongst clinicians in their therapy area.
• Friendly, family culture where your career will be nurtured.

WHAT YOU WILL LEAD AND BUILD

• This Senior Regulatory Affairs & Quality ANZ role reports to the Associate Director of Quality and Regulatory Affairs.
• The position will manage ANZ regulatory submissions, registrations and lifecycle activities across medical devices.
• The role will prepare and submit applications, variations and change notifications to TGA & Medsafe.
• You will support post-market surveillance activities including incident reporting, recalls, and FSCAs.
• You will review product changes and assess regulatory impact to ensure ongoing ANZ compliance.
• You will partner with Sales, Marketing, Clinical, Supply Chain and Technical teams to support commercial initiatives and product launches.
• You will review promotional and marketing materials for compliance with ANZ regulatory and advertising requirements.
• You will support complaint handling, quality documentation and local QMS maintenance within GMP and ISO13485 environments.

WHAT EXPERIENCE WILL BE CONSIDERED?

• Minimum 3 years Regulatory Affairs and Quality experience within the pharmaceutical and/or medical device industries.
• Proven experience managing ANZ regulatory submissions, registrations, variations and lifecycle activities.
• Strong working knowledge of TGA & Medsafe regulatory requirements.
• Experience within GMP and ISO13485 regulated environments.
• Exposure to post-market surveillance activities including incident reporting, recalls, FSCAs.
• Experience supporting and/or managing medical device compliance activities across Class I–III products.
• Strong understanding of Quality Management Systems, risk management and regulatory compliance processes.
• Excellent stakeholder engagement skills with the ability to work cross-functionally across commercial, quality and technical teams.
• Degree qualified in Science, Engineering, Healthcare or a related discipline.
• Full Australian working rights with the ability to work onsite 5 days a week in Macquarie Park, accessible via nearby paid parking, train and metro transport options.

Interested?
Please apply now quoting reference number 3839 and/or call Nicole Villanueva on 0414.919.461. Please note, your details/resume will not be sent anywhere without a formal interview and, if successful, your subsequent prior permission. Personal information provided will be used for recruitment purposes only and be treated in the strictest confidence. Only shortlisted candidates will be contacted.