Senior Regulatory Affairs Specialist

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Medtronic is a market leader, and our expanding portfolio delivers measurable clinical and economic value – and opens doors. With a passion for helping patients and a commercial mindset, you will make a significant difference together with Medtronic Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations. This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care. The Senior Regulatory Affairs Specialist (RAS) will help in planning and executing global regulatory activities necessary to obtain and maintain regulatory approvals within ANZ and other markets within the Asia Pacific region (as required). This position ensures compliance with required global regulations and Medtronic policies for Diabetes products and serves as a key team member and/or in a lead role on extended team(s). Responsibilities Directs or coordinates preparation of document packages for regulatory submissions, internal audits, and inspections. Leads or compiles all materials required for submissions, license renewals, and annual registrations. Recommends changes for labelling, manufacturing, marketing, and clinical protocol to ensure regulatory compliance. Monitors and improves tracking/control systems. Keeps abreast of regulatory procedures and changes. May direct interaction with regulatory agencies on defined matters. Partner with local country RA affiliates to help planning, developing, and executing global Interact with Regional RA team within APAC region and provide support needed. Support and strengthen communication process between international RA and Diabetes unit RA team. Reviews Change Orders and assess regulatory impact of product changes on International regulatory strategy and submissions per standard procedures. Participate and represent OUS regulatory function in sustaining (Including MDR) and new product development projects to provide OUS regulatory requirements. Assist in keeping company informed of regulatory requirements in ANZ. Supports product demand planning and release activities. Follow all assigned standard operating procedures and company policies to ensure compliance. Supports all post markets regulatory requirements and audit requests. Partner with local affiliates to help planning and executing license transfer and rebranding duties for the region. Other duties as assigned or required. Required Knowledge and Experience Bachelor’s degree required with a minimum of 3-5 years of medical device regulatory affairs experience. Medical Device regulatory submission/approval experience. Knowledge of TGA and Medsafe regulations/ requirements. Knowledge of Asia Pacific regulations/requirements is preferred (eg PMDN, MFDS, TFDA..etc). Strong Interpersonal and analytical skills. Strong communication and technical writing skills. Attention to detail. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package. A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here. #J-18808-Ljbffr