Do you want to help create the future of healthcare? Our name, Siemens Healthineers, was selected to honour our people who dedicate their energy and passion to this cause. It reflects their pioneering spirit combined with our long history of engineering in the ever-evolving healthcare industry. We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting? We have an exciting opportunity for a Quality and Regulatory Affairs Officer to join our business in a fixed term capacity for 12 months with the potential to extend to a permanent position. Reporting to the Head, Regulatory Affairs and Quality System (Australia and New Zealand), this role will be central to support the delivery of quality and regulatory compliance to Siemens Healthcare locally and supporting the global Siemens Healthcare Quality and Regulatory global network. This position will present an excellent opportunity for an enthusiastic individual looking to gain experience and exposure to quality and regulatory affairs in a large global organization, with scope to develop his/her skills further. The role will initially be based in Bayswater and will move to our new office in Hawthorn East later in the year. This position can be worked flexibility with a combination of office attendance and work from home arrangements. Skills The ability to produce accurate work, to work to strict deadlines, the ability to maintain confidentiality, outstanding interpersonal and communication skills are essential for success in this role. Excellent written and oral communication, strong technical and scientific aptitude and proficiency in MS Office are required for this role. Responsibilities Key responsibilities will include: General: · Liaison between local and global colleagues within Siemens Healthcare Quality and Regulatory global network. · Facilitation and coordination of information resulting from meetings and workshops. · Based in the Melbourne office and may involve some local and interstate travel. Quality · Support staff in the Quality System documentation requirements, to act as a Document Controller to ensure that internal quality documents are maintained and kept current · Support with internal and external audits · Support in the maintenance of quality databases · Support the ongoing conformance to applicable standards such as ISO 9001:2015 Regulatory · Support in Post Market processes including Field Safety Corrective Actions, including collating of customer responses to ensure timely reporting to authorities · Support in maintaining timely and accurate registration of products and licences · Support in the maintenance of regulatory databases · Support in the timely and accurate submission and maintenance of import and export licences and permits Qualifications Qualification in the Health Sciences and experience in Healthcare or a related Quality and Regulatory discipline, is desirable. The position is a fixed 12-months contract to assist the team with a maternity leave cover, with a potential to further expand to permanent full-time. You must be able to provide evidence of your eligibility to work in Australia. If you want to join us in transforming the way healthcare is delivered, get in touch with us today. Applications close 23 July 2021, or sooner, if sufficient applications received. Being part of our team: Siemens Healthineers is a leading global medical technology company. 50,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. Curious about our culture? Our culture embraces different perspectives, open debate, and the will to challenge convention. Change is a constant aspect of our work. We aspire to lead the change in our industry rather than just react to it. That’s why we invite you to take on new challenges, test your ideas, and celebrate success. We are an equal opportunity employer. Organization: Siemens Healthineers Company: Siemens Healthcare Pty. Ltd. Experience Level: Experienced Professional Job Type: Full-time