Senior RAQA Specialist

Terumo Malaysia Sdn Bhd; Selangor; Sur place; MYR 45 000 - 70 000; Plein temps

Résumé du poste

Terumo Malaysia Sdn Bhd is hiring for a role focused on Regulatory Affairs and Quality Assurance, ensuring compliance with local and international standards. Candidates should have at least 3 years of experience in regulatory affairs or quality assurance in the medical device industry.

The position involves maintaining product registration, managing the Quality Management System, and collaborating across departments to meet compliance and quality standards while mentoring junior team members.

Qualifications

• Minimum 3 years of regulatory affairs & quality assurance experience in the medical device, pharmaceutical, or healthcare industry.
• Knowledge of relevant regulations like the Medical Device Act 2012 and EU Medical Device Regulation.
• Experience with internal and external auditing processes.

Responsabilités

• Manage registration of medical device products in Malaysia.
• Ensure compliance with local and international regulatory requirements.
• Maintain and improve the Quality Management System (QMS).
• Handle product complaints and reporting to authorities for adverse events.
• Provide coaching to junior RA/QA team members.

Connaissances

Detail-oriented

Excellent communication

Strong organizational skills

Knowledge of GDP-MMD

ISO13485

Medical Device Regulations knowledge

Formation

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

Description du poste

Key Responsibilities

• Regulatory Affairs (RA)
  • Responsible for maintaining registration of medical device products in Singapore, Malaysia, and Emerging Markets (Myanmar, SriLanka, Bangladesh, Cambodia, Laos, Brunei, Nepal, Maldives, Bhutan, and EastTimor 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)
  • Manage distributor registration matters, local labelling, and regulatory reporting
  • Maintain regulatory database and report regularly
  • Track regulatory compliance and research regulatory‑related information and updates
• Quality Assurance (QA)
  • Maintain and improve the Quality Management System (QMS) in accordance with applicable standards (e.g., GDP‑MMD, 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
• 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
• Registration
  • Maintain registration of medical device products in Malaysia (dossier preparation, compilation, submission, follow‑ups, monitoring, and approval)
• Post‑market Surveillance
  • Handle product complaints and reporting to authorities for any adverse event or non‑conformance
  • Handle product disposal and liaise with warehouse and distributors
• Quality Management System
  • Maintain the company’s QMS and ensure compliance with GDP‑MMD
  • Develop/update SOPs for work processes within the department and inter‑department
  • Assist in preparing and participating in internal and external audits
• Networking
  • Liaise and negotiate with regulatory parties (MDA, SIRIM, NPRA, etc.) to ensure successful registration within timeframe
  • Track regulatory compliance and research regulatory‑related information and updates
• Reporting
  • Maintain regulatory database and report regularly
  • Provide strategic oversight of MDIA‑related regulatory activities, acting as 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. 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 GDP‑MMD, ISO13485, Medical Device Act2012 (Act737), Medical Device Regulations2012, EU Medical Device Directive93/42/EEC (MDD), and EU Medical Device Regulation (EUMDR2017/745). Experienced in internal, supplier, and/or external auditing processes, including audit preparation, execution, and follow‑up actions.

Education & Experience

Minimum 3years of regulatory affairs & quality assurance experience in a medical device, pharmaceutical or healthcare industry (or related fields). Minimum requirement of a Bachelor’s degree or diploma in pharmacy, medical science or related studies.