APAC Senior Quality & Regulatory Manager - MiniMed job opportunity at Medtronic plc.

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DateMore Than 30 Days Ago bot
Medtronic plc APAC Senior Quality & Regulatory Manager - MiniMed
Experience: 7-years
Pattern: full-time
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loacation Macquarie Park, New South Wales, Australia, Australia
loacation Macquarie Park..........Australia

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 We are seeking a APAC Senior Quality & Regulatory Manager to lead a regional team and advance the strategic direction of quality and regulatory initiatives, ideally, to be based in either Australia or India location. This role oversees a group of professionals responsible for delivering tactical, operational, and strategically aligned activities within the region. The Manager will focus on guiding team performance, developing talent, and fostering an engaged, inclusive work environment. Key responsibilities include mentoring and coaching staff, conducting performance reviews and 1:1 meetings, and driving employee development to meet departmental and organizational objectives. In addition to day-to-day oversight, the role contributes to broader strategic planning by setting priorities, allocating resources, and ensuring alignment with departmental and enterprise initiatives. Success is achieved through effective leadership of direct and indirect reports and the ability to translate strategic goals into measurable outcomes. 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. Responsibilities may include the following and other duties may be assigned: Provides oversight for the development, implementation, and maintenance of regional quality programs, systems, and processes to ensure compliance with internal policies and with applicable external standards, regulations, and guidelines. Offers expert guidance in interpreting policies, regional regulatory requirements, and government regulations, ensuring consistent compliance across all operational areas. Partners with regional operating entities to review and analyze processes, ensuring quality and regulatory requirements are met and driving continuous process improvement. Leads audit and inspection readiness efforts, including preparation, facilitation, and response activities, and serves as the primary liaison with auditors, inspectors, and regulatory authorities throughout all phases of audits and inspections. Prepares and oversees required documentation and reports, such as Corrective and Preventive Actions (CAPAs), regulatory submissions, and other quality records, and ensures timely communication to internal and external stakeholders. Coordinates responses to legal or regulatory information requests, including those related to government investigations or litigation, in collaboration with Legal and Compliance partners. Ensures quality assurance programs, processes, and policies are regularly reviewed, updated, and maintained to reflect evolving regulatory expectations and business needs. Drives consistency in quality and regulatory standards across the region, promoting harmonization, sharing of best practices, and alignment with global quality objectives. Required Knowledge and Experience: Bachelor’s degree with a minimum of 7 years of relevant experience with 5+ years of managerial experience Leads a multi-team department or regional unit with significant autonomy and decision-making authority. Makes major business, strategic, and compliance-related decisions that impact performance and organizational reputation. Drives innovation and continuous improvement through best practices, AI utilization, and regulatory intelligence sharing. Enhances or redesigns processes, systems, and services to improve compliance, efficiency, and operational excellence. Influences cross-functional and cross-regional stakeholders to align priorities and resolve differing operational objectives. Demonstrates mastery-level technical and regulatory expertise to guide decisions, ensure compliance, and support strategic planning. 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    

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