RA/QA Manager ANZ

Company description:Senior Manager RA & QA - APAC Established Global Healthcare Provider Collaborative Team Growth & Development Opportunities The Position: Zimmer Biomet, a global leading healthcare provider, invite applications for a Senior Manager, Regulatory Affairs & Quality Assurance APAC to join our team in Sydney, Australia. The Senior Manager RA & QA's primary responsibility is to monitor and evaluate the safety, efficacy and performance of Zimmer Biomet's products. This role is responsible for the post market surveillance from compliance to legislation and working with both the Therapeutic Goods Association & Medsafe. You will be responsible for regional regulatory strategic and operational tasks for a range of development and registered products in the Asia Pacific (APAC) Region. Job description: Skills and Experience: Analytical and data driven, the successful applicant will be able to tell a story derived from expert analysis. You will have strong regulatory understanding of the ANZ environment and be able to work to tight deadlines. The successful Senior Manager, RA & QA APAC will: Work with global and regional teams to ensure all pre and post market activities are conducted in accordance with relevant legislative requirements. Manage the channels for Zimmer Biomet representatives to report incidences. Analyse and report on Post Market trends whilst managing the evolving regulatory changes. Be the Zimmer Biomet point of contact for the TGA and Medsafe. Project manage regulatory activities in support of new product launches by working closely with PD teams whilst working within the framework of New Product Development/Stage Gate process and IBP. Strong regulatory experience in a regulatory authority facing role, supported by additional industry experience. Demonstrated working knowledge of regulatory guidelines and legislative requirements for Australia/New Zealand and other APAC markets. Profile description:Employee Benefits· 12 Week Paid Parental Leave for Primary & Secondary Carers· Extra Day's Leave Each Year for Birthday· 5 Year Service Anniversary Leave· Picnic Day (Additional ZB Day's Leave)· Volunteer LeaveAbout UsAs the leading innovator in musculoskeletal healthcare, our cutting-edge robotics technology, interactive digital platforms, and comprehensive portfolio of products for joint reconstruction, bone and skeletal repair, sports and spinal injuries, help restore mobility, alleviate pain, and improve the quality of life for patients. Collaborating with top healthcare professionals around the globe to speed up the pace of innovation, and expand the possibilities for successful treatment outcomes, Zimmer Biomet remains committed to our promise to look beyond what's possible now and discover what's possible next.Applicants MUST be eligible to live and work in Australia.At Zimmer Biomet ANZ, we are about transforming orthopaedics, and we believe in the need for Surgeons and Patients to have access to the combination of cutting-edge technology and implants to give patients the best opportunity to improve their quality of life. Interested? Click APPLY and attach your most recent CV including your contact details.