Quality and Regulatory Affairs – Part Time – Medical Devices Manufacturing

Quality and Regulatory Affairs – Part Time – Medical Devices Manufacturing Austramedex Group operates two complementary medical device manufacturing businesses: Austramedex and Austramedex Solutions. With over 60 years of combined manufacturing excellence at our Hallam and Knoxfield facilities in Victoria, we are a trusted partner for consumables, contract manufacturing, and specialty procedure packs. We serve healthcare professionals and patients across Australia with a large variety of products/solutions. The Opportunity We're seeking an experienced Quality and Regulatory Affairs Specialist to join our team on a part‑time basis. You'll play a critical role in managing quality standards and regulatory compliance across both Austramedex and Austramedex Solutions operations, ensuring our consumables, contract manufacturing products, and procedure packs meet the highest quality and safety standards while maintaining full compliance with Australian regulations. The Role Quality Management Overseeing the quality management system across both sites, ensuring consistency with ISO 13485 standards and company policies Assisting with production schedules across consumables, contract manufacturing, and procedure pack lines to optimise efficiency while maintaining quality standards Helping to ensure raw materials and components are available to support production timelines and meet quality specifications Supporting quality processes for both ETO (Ethylene Oxide) and Gamma sterilisation Maintaining comprehensive quality documentation and ensuring adherence to manufacturing standards and regulatory requirements Regulatory and Compliance Managing regulatory compliance across both manufacturing sites in accordance with TGA requirements Liaising directly with the Therapeutic Goods Administration (TGA) on compliance matters, investigations, post‑market surveillance, and regulatory submissions Ensuring ongoing compliance with relevant medical device regulations and standards Managing quality incidents, deviations, and corrective actions Supporting continuous improvement initiatives and process improvements across both facilities Maintaining regulatory documentation and records What We're Looking For Extensive experience with ISO 13485 medical device quality management systems Background in medical device manufacturing quality and regulatory affairs Minimum 1–2 years of experience in medical device manufacturing quality and regulatory affairs Strong knowledge of Australian TGA regulations and medical device compliance requirements Previous audit experience, including external audit experience Understanding of sterilisation processes (ETO and/or Gamma sterilisation experience highly valued) Experience managing regulatory submissions and TGA communications Attention to detail with strong analytical and problem‑solving skills Professional communication skills and ability to work cross‑functionally Reliability and commitment to quality and regulatory excellence Ability to work autonomously Australian work authorisation is required for this position Experience with quality management systems Previous liaison experience with regulatory bodies Knowledge of consumables and procedure pack manufacturing Manufacturing or production environment experience Experience with contract manufacturing operations Understanding of quality incidents and corrective action management Experience with post‑market surveillance and adverse event reporting What We Offer Flexible part‑time arrangements to suit your lifestyle Work across two well‑established manufacturing facilities Opportunity to contribute to healthcare innovation across consumables, contract manufacturing, and procedure pack sectors Professional development in a quality and regulatory‑focused organisation Access to experienced team members with decades of manufacturing expertise Competitive compensation package commensurate with experience Location & Schedule This role is based across our Hallam and Knoxfield manufacturing facilities in Melbourne, Victoria. Part‑time hours are flexible and will be discussed during the recruitment process to align with business needs and your availability. The expected weekly time commitment for this part‑time role is 21–25 hours. How to Apply Your resume/CV A cover letter outlining your relevant quality and regulatory affairs experience and interest in the role About Austramedex Group Established with over 60 years of combined manufacturing excellence, Austramedex Group operates through Austramedex and Medical Concepts Australia, specialising in consumables, contract manufacturing, and medical device procedure packs. Our commitment to quality, regulatory compliance, and innovation ensures healthcare professionals have access to premium products that enhance patient outcomes. #J-18808-Ljbffr