Regulatory Operation Specialist

An exciting opportunity for has arisen for a Regulatory Operations Specialist to join our International Regulatory Affairs team based in our Macquarie Park office. 

Reporting to the Regulatory Affairs Director, this role performs a broad range of regulatory operational activities including analyses, evaluation, preparation, and management of regulatory intelligence, regulatory product releases, documentation, support of internal and external audits, and general support of regulatory activities. As Regulatory Operations Specialist you will represent Regulatory operations in cross-functional interactions with Supply Chain, Customer Support, Quality, and IT.

Your responsibilities include (and not limited to):

• Monitor medical devices regulatory environment, assesses regulatory intelligence and input information into the relevant database
• Review and approve advertising/promotion material to ensure regulatory compliance
• Support product releases by assisting on Product Release Authorisation (PRA) submission and approvals
• Supply chain support as a regulatory representative responsible for review and resolution of GTS blocked orders
• Ensure post-approval commitments to regulatory authorities are planned, tracked, and delivered on-schedule
• Management of regulatory documents and records in Global Product Registration (GPR) system and overall regulatory operations activities
• Participate and/or lead various projects in regulatory departmental process improvement initiatives
• Represent Regulatory operations in cross-functional interactions with Supply Chain, Customer Support, Quality, and IT
• Collaborate with cross-functional departments to ensure regulatory requirements are met and integrated in the Quality Systems
• Participate in internal and external audits; provide regulatory input and appropriate follow up
• Interact with regulatory agencies on defined matters

Who we’re looking for:

• Degree qualification in sciences, engineering or related discipline
• Minimum 1 years’ experience in Regulatory Affairs with working knowledge of medical devices legislation
• Must be computer literate with experience in Microsoft applications as required; Quality Systems experience beneficial
• Excellent communication and strong interpersonal skills
• Proactive and resilient self-starter that thrives in a fast-paced innovative environment
• Demonstrated ability to plan and prioritise with very high attention to detail

Due to the inherent requirements of the role, the preferred candidate must provide evidence of full COVID-19 vaccination before the commencement date and maintain a fully vaccinated status for the period of employment.

Abbott provides some fantastic benefits for our employees, these include:

• Free parking, onsite gym and Barista at our Macquarie Park office
• Leading Learning and Development opportunities
• Wellness programs
• 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 115,000 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 by refraining from contacting us or forwarding unsolicited profiles.