Senior RAQA Specialist

Terumo; Malaysia; On-site; MYR 90,000 - 150,000; Full time

Job summary

Terumo Malaysia is seeking a Regulatory Affairs and Quality Assurance professional to maintain registrations for medical device products across Malaysia and emerging markets. The role involves planning regulatory submissions, ensuring ongoing compliance with local and international requirements, and coordinating audits across internal and external stakeholders.

You will support post‑market surveillance, complaints, CAPA, and change control, while mentoring junior team members and driving

Qualifications

• Bachelor’s degree or diploma in pharmacy, medical science or related fields.
• Minimum 3 years of regulatory affairs & quality assurance experience in medical devices/pharma.
• Experience with GDPMD, ISO 13485, regulatory submissions and audits.

Responsibilities

• Maintain registration of medical device products in Malaysia and listed regions.
• Plan, prepare, and manage regulatory submissions and change notifications.
• Support and lead internal and external audits and CAPA processes.
• Manage documentation, complaint handling, vigilance and post‑market surveillance.
• Act as RA/QA liaison to cross‑functional teams and management.

Skills

Detail‑oriented

Cross‑functional collaboration

Regulatory awareness

Quality mindset

Communication

Auditing

Decision making

Project management

Education

Bachelor’s degree or diploma in pharmacy/medical science or related

Job description

About the Company

As a global medical device company originating from Japan, we pursue reliable quality and technology to contribute to healthcare in more than 160 countries and regions around the globe. We promise to walk alongside healthcare professionals to continue to make great contribution to society, now and into the future.

Summary of the Role

1. Regulatory Affairs (RA)

• Responsible for maintaining registration of medical device products in Singapore, Malaysia, and Emerging Markets (Myanmar, Sri Lanka, Bangladesh, Cambodia, Laos, Brunei, Nepal, Maldives, Bhutan and East Timor Market)

• Plan, prepare, and manage regulatory submissions and change notifications

• Ensure ongoing compliance with local and international regulatory requirements (e.g., HSA, MDA, FDA, EU MDR/IVDR, ISO standards).

• Distributor management in terms of registration matters, local labelling, and regulatory reporting

• Maintain regulatory database and report regularly.

• Keep track and ensure regulatory compliance and research on regulatory‑related information/ updates.

2. Quality Assurance (QA)

• Maintain and improve the Quality Management System (QMS) in accordance with applicable standards (e.g., GPDMD, GDP).

• Ensure compliance with procedures, work instructions, and quality records.

• Support and/or lead internal audits, supplier audits, and external audits/inspections.

• Manage AE, CAPA, deviations, non-conformities, and change control activities.

• Develop, Review and approve quality-related documentation (e.g., SOPs, risk files, validation records).

• Support complaint handling, vigilance, and post‑market surveillance activities.

• Ensure appropriate training and awareness of quality and regulatory requirements.

3. Cross‑Functional & Leadership Responsibilities

• Act as a key RA/QA contact for internal stakeholders (SCM, Manufacturing, Commercial, Medical).

• Provide coaching or mentoring to junior RA/QA team members.

• Support continuous improvement initiatives related to compliance, efficiency, and risk reduction.

• Participate in management reviews and quality/regulatory governance forums.

• Represent RA/QA in project teams and business initiatives.

• Ad hoc duties assigned by supervisor/management

Key Functions / Responsibilities

1. Registration

• Responsible for maintaining registration of medical device products in Malaysia

• Involve with the registration dossier preparation & compilation, submission, follow ups, monitoring and obtain approval.

2. Post‑market Surveillance

• Handles product complaint and reporting to Authority for any adverse event or non-conformance found.

• Handles product disposal and liaise with warehouse & distributors.

3. Quality Management System

• Maintaining the quality management system of the company and ensure compliance with GDPMD.

• Involved in developing/updating SOPs for work processes within department and inter department.

• Assisting / Preparing/ Participating in internal and external audits.

4. Networking

• Liaise and negotiate with different parties (MDA/SIRIM/NPRA/etc) whenever necessary to ensure successful registration within timeframe.

• Keep track and ensure regulatory compliance and research on regulatory‑related information/ updates.

5. Reporting

• Maintain regulatory database and report regularly.

• Provide strategic oversight of MDIA‑related regulatory activities, acting as a key liaison between local requirements and regional quality systems.

Functional / Technical Skills

• Detail‑oriented, meticulous, and highly organized with a strong focus on accuracy and compliance.

• Works collaboratively across functions and levels of the organization to achieve shared objectives.

• Communicates effectively by providing timely, clear, and practical information to stakeholders across the organization.

• Builds and maintains strong working relationships across multiple functions and geographic locations.

• Demonstrates persistence and resilience in accomplishing objectives despite obstacles or setbacks.

• Able to objectively evaluate options by assessing pros and cons, risks, and benefits to support sound decision‑making.

• Shows strong personal accountability and commitment to continuous improvement.

• Demonstrates sound judgment by adapting approaches to suit different situations and business needs.

• Flexible and adaptable, with proven ability to support and manage change in a dynamic environment.

• Knowledgeable in GDPMD, ISO 13485, Medical Device Act 2012 (Act 737), Medical Device Regulations 2012, EU Medical Device Directive 93/42/EEC (MDD), and EU Medical Device Regulation (EU MDR 2017/745).

• Experienced in internal, supplier, and/or external auditing processes, including audit preparation, execution, and follow‑up actions.

Education & Experience

• Qualifications of Bachelor’s degree or diploma in pharmacy, medical science or related studies

• Minimum 3 years of regulatory affairs & quality assurance experience in a medical device/pharmaceutical/ healthcare industry or related fields