An exciting opportunity has come up for a motivated Regulatory Affairs Specialist to join our team to provide Regulatory Affairs support to our Structural Heart business at Abbott. Reporting to the Regulatory Affairs Director, you will be based in our head office at Macquarie Park.

This is a 12-month parental leave contract.

Your responsibilities include (and not limited to):

• Filing TGA and Medsafe regulatory submissions
• Supporting company sales targets through timely product approvals in line with Marketing launch plans and reimbursement strategies
• Building relationships and maintaining regular contact with US colleagues to review status of all projects and participate in discussions
• Reviewing changes notified by the manufacturer for currently approved devices and assessing the need for review/ approval by TGA
• Providing RA status reports and maintaining internal spreadsheets/databases
• Reviewing promotional materials for compliance with MTAA and TGA requirements
• Providing regular training on ANZ regulatory requirements to US regulatory and product expert colleagues to facilitate understanding, optimise support for ANZ submissions and training to ANZ commercial teams as required
• Assisting Post Market Surveillance to handle and document customer complaints according to Abbott procedures and policies
• Supporting the RA Director and Quality Department with implementation and reconciliation of field safety corrective actions when required
• Actively participate in MTAA and MTANZ and contribute to industry input on proposed regulatory reforms and government inquiries
• Reviewing TGA consultation documents and providing feedback through MTAA or independently as appropriate

Who we’re looking for:

• Tertiary qualifications in science/ engineering/ health or related discipline essential
• Minimum of 12 months in Regulatory Affairs role within medical devices industry
• Excellent communication skills and ability to build respectful relationships with a diverse range of stakeholders, including internal, customers and regulators
• Excellent attention to detail
• Collaborative approach to teamwork

Due to the inherent requirements of the role, the preferred candidate must provide proof of full COVID-19 vaccination before commencement and maintain their vaccination status.

What we offer you!

• Discounted Shares program
• Wellness Programs
• Professional and Personal development opportunities
• Being part of an organisation reputed to be a World’s Top Employer recognised for our workplace culture that values healthy living, diversity and equal opportunity

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.

Abbott is committed to building a diverse workforce that values diversity across gender, age, culture, disability and lifestyle.

In order to be eligible to work for Abbott in Australia or New Zealand, you must hold current working rights with no restrictions, for the respective country applicable.

We ask that recruiters respect our internal recruitment process and PSA panel, and refrain from contacting us, or referring candidates to this role.