Regulatory Operation Specialist - Sydney, Australia - Abbott Laboratories

Abbott Laboratories

Verified Company

Sydney, Australia

2 weeks ago

Posted by:

Olivia Brown

beBee Recruiter

Description

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 postapproval commitments to regulatory authorities are planned, tracked, and delivered onschedule
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 crossfunctional interactions with Supply Chain, Customer Support, Quality, and IT
Collaborate with crossfunctional 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 3 years experience in Regulatory Affairs with working knowledge of medical devices legislation
Excellent communication and strong interpersonal skills
Proactive and resilient selfstarter that thrives in a fastpaced innovative environment
Demonstrated ability to plan and prioritise with very high attention to detail

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.