Senior RA/QA Specialist - #1165180

• US MNC

• Hybrid work arrangement

• 1 year contract with full benefits + bonus

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 - 6 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.

• 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 ash•••@peopleprofilers.com

We regret that only shortlisted candidates will be notified

People Profilers Pte Ltd

Tel: 69••753

EA Registration Number: R1111375

EA licence number 02C4944

EA Personnel: Lee Hui En Ashley