Quality & Regulatory Affairs Lead, Sg

**Careers that Change Lives**

Together, we will change healthcare worldwide. Join us in our Mission to alleviate pain, restore health and extend life worldwide. Let’s work together to address the universal healthcare needs and improve patients’ lives, optimize costs and efficiencies, and expand global access. Together, we can make a real difference in the global disparity in care. By providing quality care at the lowest possible cost, we will succeed as a company, and take the future of healthcare Further, Together.

**A Day in the Life**

**Regulatory Affairs (70%)**
- 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, SGMY, effective strategies to cope with issues related to product registration, radiofrequency and clinical trials.
- To strategize ways to improve work efficiency across RA team and work processes.

**Quality (30%)**
- To ensure compliance of Medtronic operations in Singapore 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 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, SGMY, effective strategies to cope with issues related to quality.
- To strategize ways to improve work efficiency across QA team and work processes.

**Must Have: Minimum Requirements**
- Bachelor's degree required
- Minimum of 3 years of relevant experience, or an advanced degree with a minimum of 1 year of relevant experience
- **_Your vaccination status shall be collected during the interview and selection process referencing and in line with the Safe Management Measures at the workplace stipulated by the Ministry of Manpower_**

**Nice to Have**
- Bachelor’s Degree in Science or Engineering/ Quality Management or related discipline.
- Min 6-8 years experience in regulatory affairs and quality management system.
- Regulatory Affairs in Medical Device industry is highly preferred
- Work experience in a MNC in a similar industry is preferred
- Experience in preparing and submitting CSDT & dealing with local regulatory agencies
- Demonstrated experience with the Singapore Medical Device Regulations
- Good understanding of GDP and ISO 13485 and its implementation is required.
- Experience in conducting training and ability to impart knowledge and experience to participants.
- Previous experience in conducting internal quality audits and managing external audits.
- Understands basic management approaches such as work scheduling, prioritizing, coaching and process execution
- Previous experience in leading a team
- Excellent verbal, written, negotiation, and interpersonal communication skills
- Good written and spoken English ability
- Computer literacy including sound knowledge of the MS Office suite of software

**About Medtronic**

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

**Physical Job Requirements**

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand