Snr QA/RA Specialist (MNC)

Key Responsibilities: Regulatory Affairs: Product Registration:  Lead the preparation and submission of KGMP and product registration dossiers to the Ministry of Food and Drug Safety (MFDS), ensuring timely approvals.

Compliance & Maintenance:  Manage license renewals, variations, and updates to the MFDS. Maintain accurate records in our Regional HQ databases and ensure all product documentation is current.

Labeling & Advertising:  Review and approve marketing materials and product labels to ensure they align with MFDS-approved claims and regulatory standards.

Strategic Monitoring:  Monitor the regulatory landscape for new requirements, assessing business impact and keeping Regional HQ informed of emerging trends.

Stakeholder Support:  Act as a key regulatory advisor, supporting distributors and sales teams with technical product data.

Quality Management & Assurance: System Management:  Maintain and enhance the Quality Management System (QMS) in compliance with MFDS regulations and corporate policies. Lead internal training initiatives to foster a culture of quality.

Audits & Inspections:  Conduct internal audits and manage 3PL warehouse inspections to ensure seamless readiness for regulatory body evaluations.

Complaint Handling:  Manage local product quality complaints, collaborating with Regional QA teams to drive timely investigations and resolutions.

Supply Chain Oversight:  Partner with local Supply Chain to oversee 3PL activities, including incoming inspections and deviation/reworks, ensuring strict adherence to Regional procedures.

Requirements: Bachelor’s degree in Science, Lifescience, Engineering with 3 - 5 years of regulatory, reimbursement, quality management system and quality experience in medical device company. Knowledge in ASEAN Medical Device Directive, US FDA medical device regulation or EU Medical Device Regulation would be advantageous. Must have good knowledge and understanding of Technical Files and product registration process. Familiar with design and development, manufacturing testing in order to understand the technical reports for product registration submission. Familiar with standard related to Quality Management Systems (ISO 13485) with internal auditor certification. Good Technical report writing skills. 1 year direct contract with full benefits. JOBID: JOB-00544 All Successful candidates can expect a very competitive remuneration package and a comprehensive range of benefits. Kindly email your resume in a detailed Word/pdf format to ashley@peopleprofilers.com   We regret that only shortlisted candidates will be notified People Profilers Pte Ltd Tel :   6950 9753 EA Registration Number: R1111375 EA licence number 02C4944 EA Personnel: Lee Hui En Ashley