Quality Assurance and Regulatory Affairs Associate

Location: 321 Kent Street Sydney
Employment: Full Time
Closing Date: 28/04/2021

Genea Biomedx is part of the Genea Group, a world leading fertility organisation. Working hand in hand with fertility scientists to create consistently better outcomes for clinics and their patients, we plan to make a big impact on the way things are done in fertility - by transforming our immense wealth of expertise into practical, accessible, precise technology that aims to significantly improve lab outcomes and ultimately patient outcomes.

THE ROLE

Currently we have an opportunity for an experienced Quality Assurance and Regulatory affairs Associate to join our team taking on an autonomous role. We have an extensive product range and you will take primary responsibility for allocated components of the quality management system (QMS). Broadly your duties will include: 

  • Perform regulatory affairs duties including implementation of strategies, negotiating approvals, preparation, review and approval of technical documentation for compliance and submitting applications
  • Support development, implementation and maintenance of the Genea Biomedx QMS.
  • Perform QA duties to deliver quality objectives
  • Production quality oversight
  • Batch release and business related QA tasks
  • Assist with QMS administration delivery

REQUIRED EXPERIENCE

This role will suit an experienced QARA Associate, someone who has a strong working knowledge of ISO 13485. Ideally you will have worked in the Medical Devices industry and be familiar with European and Australian regulatory requirements. You will be confident in working autonomously and managing your own objectives, possess an excellent attention to detail and be motivated to learn and develop as the business grows and changes. 

WHAT WE OFFER

This is a great opportunity for an experienced Quality Associate and Regulatory Affairs Associate to transfer their skills into a growing, dynamic medical devices business. You will be working with leading technology developed to provide first class outcomes for our patients. At Genea we offer a supportive and flexible work environment, excellent staff benefits (social club, health and wellbeing program + corporate discounts) and plenty of opportunity for learning and development.