Job Description

Careers That Change Lives

We\xe2\x80\x99re 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, radiofrequency and quality issues.
• Prepare submissions and product information changes as required by government legislation.
• Support internal systems and processes, relating to regulatory and quality, e.g. SAP, GCH, Insight, Trackwise, MAP Agile, etc.
• Maintain databases of regulatory submissions, approvals and Quality metrics.
• Provide monthly report including submission and approval status, regulation, quality metric and others relevant policy changes to Head of Quality & Regulatory Affairs.
• Support guidelines for product approval and processes and inform business units\xe2\x80\x99 regulatory affairs staff of data necessary for inclusion in submissions.
• Support country organization\xe2\x80\x99s compliance with the laws and regulations governing product registration and reimbursement.
• Coordinate and maintain product complaint handling system.
• Coordinate clinical trials and related activities.
• Responsible for coordination of product field corrective action and related activities.
• Identify and resolve issues in a timely manner.
• Support in achieving assigned goals and KPI
• Other duties assigned by the immediate Manager

Must Have

• Bachelors degree required
• Minimum of 1 year of relevant experience

Nice to Have

• Bachelors degree in Science or Engineering/ Quality Management or related discipline
• Experience in regulatory affairs and quality management system.
• Work experience in a multinational company in a similar industry is preferred.
• Experience in preparing and submitting CSDT & dealing with local regulatory agencies.
• Demonstrated experience with the Malaysia 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.
• 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\xe2\x80\x99s work together to address universal healthcare needs and improve patients\xe2\x80\x99 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 the Work Conditions and Physical requirements that may be specific to each role.

Other Comments and Requirements:

• Regional and overseas travel at short notice.

Additional Information

• Posting Date: Jun 22, 2023
• Travel: Yes,

Medtronic