Quality and Regulatory Affairs Lead

3 months ago

Kuala Lumpur, Malaysia Medtronic Full time

**Careers That Change Lives
**We’re a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Join our team in Quality & Regulatory Affairs and help shape policies that change lives.

Work with us to incentivize better patient care, and partner across the industry to make healthcare more affordable and accessible. Be a part of a community of experts committed to ensuring quality, affordable healthcare worldwide.

**A Day in the Life**
- Lead Quality & Regulatory Affairs Department in Malaysia and ensuring compliance in the areas of quality, regulatory, clinical and radiofrequency.
- Support assigned Medtronic businesses in Malaysia in areas of quality, regulatory, clinical and radiofrequency.
- Keep abreast of quality and regulatory procedure and changes.
- Advocate and participate in local Quality and Regulatory initiatives.
- Recommends strategies for earliest possible approvals and solution to meet regulatory/quality requirement changes
- Maintenance and ensure validity of Medtronic operations regulatory license and quality certification.
- Support all Medtronic business locations, including distributors, 3PL (third-party logistics) and suppliers in the area of quality assurance
- Enhance Medtronic as an organization knowledgeable in quality methodology and as a provider of quality systems and services.
- Develop Quality & Regulatory Affairs (QARA) talents in career advancement

**Regulatory Affairs**
- To manage the government approval of activities such as product registration to facilitate and ensure smooth and timely introduction of new products which align with business direction.
- To keep abreast of quality and regulatory requirement changes and strategize solution to meet such changes.
- To take initiative in local regulatory activities by cultivating close relationships with government agencies as needed, to influence and respond proactively to the development of laws and regulations governing new requirements not limited to product registration, radiofrequency, quality issues.
- To develop, in coordination with Head of Quality & Regulatory Affairs, effective strategies to cope with issues related to product registration, radiofrequency and clinical trials.
- To strategize ways to improve work efficiency across Regulatory Affairs (RA) team and work processes.

**Quality**
- To ensure compliance of Medtronic operations in Malaysia to International standard, local standard and Enterprise policies by implementing, enforcing and maintaining Medtronic quality management system in timely manner.
- To implement project activities related to Quality (QA) functions and ensure implementation plans are executed according to schedule.
- To maintain quality assurance programs, policies, processes, procedures, and controls and ensuring that performance and quality of products confirm to established company standards necessary to maintain lasting customer satisfaction.
- To develop, in coordination with Head of Quality & Regulatory Affairs, effective strategies to cope with issues related to quality.
- To strategize ways to improve work efficiency across QA team and work processes.

**Key Accountabilities**:

- Build and maintain close relationships with related government agencies to establish Medtronic as an industry leader in assisting them in the formulation and implementation of fair regulations governing radiofrequency and product approval.
- Monitor changes and feedback information regarding critical development in these regulations to Head of Quality & Regulatory Affairs.
- Develop individual talent, monitors daily operations, supervision and mentoring a team of Quality & Regulatory Affairs specialist.
- Provide direction to subordinates using established policies and precedents.
- Oversee Quality team to ensure compliance and timely implementation of GDP and Enterprise policy across all Medtronic operations in Malaysia.
- Ensure Medtronic operations as an organization knowledgeable in quality methodology and as a provider of quality systems, services.
- Ensure compliance with all government regulations, legal demands and ethical standards.
- Participate in business development in the area of quality assurance.
- Coordinate with Head of Quality & Regulatory Affairs, develop effective clinical strategies. Directly involve in the clinical protocol submission process and be responsible for clearing approval and coordinating clinical trials (single or multi-centre sites) and ensuring adherence to the trial protocol and timely completion of all trials, in accordance to GCP guidelines and local regulatory requirements.
- Coordinate with Head of Quality & Regulatory Affairs, develop and maintain effective Standard Operating Procedures for the local quality and regulatory operations. Ensuring compliance to the procedure by regular internal audits.
- Proactively work with the government officials and other agencies in resolving registration, clinical, radiofrequenc

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