Senior Director QARA, Asia RLM
Senior Director QARA, Asia RLM
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Job Description
At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.
A Day in the Life
Job Title: Sr. Director Quality Assurance & Regulatory Affairs (QARA) Asia RLM
Job Summary
The Sr. Director QARA Asia RLM will be responsible for leading Quality Assurance and Regulatory Affairs (QARA) across Southeast Asia Korea and India ensuring compliance with global and regional regulatory requirements. This role involves developing and implementing quality strategies managing regulatory licensing and submission strategy and fostering a culture of quality excellence.
The Sr. Director QARA Asia RLM serves as a member of the leadership team for the Asia Region Led Market (RLM) business and the EurAsia QARA leadership team. The position plays a critical role in strategic decision-making influencing business performance and driving continuous improvement in quality and regulatory processes.
Key Responsibilities
- Lead Quality Assurance and Regulatory Affairs (QARA) activities across Southeast Asia Korea and India ensuring compliance with global and regional requirements.
- Navigate a complex matrix environment collaborating with commercial supply chain legal and global QARA teams.
- Partner with country RA leads to manage licensing submissions renewals inspections post-market surveillance and regulatory intelligence.
- Translate regulations requirements and corporate guidelines into effective business processes and procedures; stay abreast of evolving regulations and regulator expectations.
- Lead the development and strengthening of relationships with regulators and relevant industry organizations.
- In collaboration with the Global Regulatory Policy team develop and execute regional strategies to advance regulatory advocacy goals positioning the company as a reliable partner committed to patient safety innovation and regulatory excellence.
- Make strategic decisions on leveraging local capabilities versus shared services for long-term efficiency.
- Recommend changes to labeling manufacturing marketing and clinical protocols to ensure regulatory compliance.
- Develop and implement the regional quality strategy in alignment with enterprise-wide quality objectives managing the quality assurance team across the region.
- Monitor and improve tracking/control systems.
- Provide leadership coaching and mentorship to the QARA team to build leadership capabilities and foster a culture of quality compliance and operational excellence.
Experience & Qualifications
- More than 15 years of progressive experience in Quality Assurance and Regulatory Affairs preferably in the healthcare industry and ideally within the MedTech sector with significant exposure to leadership roles in multinational companies (MNCs).
- Strong collaboration and communication skills to influence effectively in a matrixed environment.
- Deep understanding of Asian regulatory frameworks especially Korea and India.
- Masters in Science Engineering or Technology preferred to facilitate communication with regulators.
- Proven strategic thinking balancing immediate compliance with long-term capability building.
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.
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 95000 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
Required Experience:
Exec
Employment Type
Full-Time
