Regulatory Affairs Associate - Post Market (37428) North Shore, Australia

Benefits

  • Work for the global leaders in medical technology
  • Attractive/Competitive salary
  • Great opportunity for professional development
  • Excellent employee engagement
  • Flexible working
  • Additional benefits, rewards and recognition

About the company

The company offers a diverse array of innovative medical technologies to help people lead more active and more satisfying lives. They offer a world-class program of medical education and training initiatives to advance expertise and care.

About the opportunity

A great opportunity to work for a successful Fortune 500 company that provides exceptional medical products and services. The RA Associate - Post‐Market will be responsible for complaint handling, Adverse Event Reporting, Product Holds and Product Field Action (PFA). This role involves coordinating activities with Regulatory Bodies and key stakeholders across the business, particularly Marketing, Sales, Regulatory and Operations.

Duties

  • Liaise with Regulatory Affairs and Marketing in relation to post-market surveillance issues and events.
  • Prepare and submit responses to TGA for post-market questionnaires and reviews in collaboration with the manufacturer.
  • Liaise with the manufacturer to determine reportability of adverse events to TGA.
  • Support the Quality team in the implementation of field safety corrective actions
  • Liaise with business partners and cross functional teams to provide support and guidance
  • Manage incidents, monitor investigation time and alert divisions.

Skills and Experience

  • Tertiary qualification in relevant scientific discipline
  • Previous experience in a similar role within a medical device organisation is highly regarded
  • Knowledge of TGA and Medsafe requirements for Medical Devices
  • Exceptional Problem-Solving and analytical skills would be a plus
  • Adept in planning and organisation
  • Excellent communication and presentation skills

Culture

Unique and inclusive culture that values people and performance at heart. Recognised as the Best Workplace in Australia. 

How to Apply

Click apply or contact Angela Barclay, Associate Director on +61 2 8877 8743 for a confidential discussion.

 

 

 

 

;