QA/RA Specialist

People Profilers Pte Ltd; Santo Niño 1st; On-site; PHP 600,000 - 900,000; Full time

Job summary

People Profilers Pte Ltd is seeking a Regulatory Affairs and Quality Assurance specialist to lead MFDS submissions, manage license renewals, and oversee QMS improvements. The role coordinates with regional teams, reviews labeling and marketing materials, and supports distributors with technical data.

Applicants should have 3–6 years in regulatory, reimbursement, and quality within a medical device company, with knowledge of ASEAN MDR, US FDA, or EU MDR advantageous, and ISO 13485 expertise.

Qualifications

• 3–6 years of regulatory, reimbursement, quality management experience in a medical device company.
• Knowledge of 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 to understand technical reports for product registration submission.
• Familiar with standards 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

Responsibilities

• Lead the preparation and submission of KGMP and product registration dossiers to MFDS, ensuring timely approvals.
• Manage license renewals, variations, and updates to MFDS; maintain records in Regional HQ databases.
• Review and approve marketing materials and product labels to ensure MFDS-aligned claims.
• Monitor regulatory landscape for new requirements and inform Regional HQ of trends.
• Act as a regulatory advisor to distributors and sales teams with technical product data.
• Maintain and enhance the QMS in line with MFDS regulations and corporate policies.
• Conduct internal audits and manage 3PL warehouse inspections for regulatory readiness.
• Oversee local QA activities and coordinate with Regional QA teams on investigations and resolutions.
• Partner with local Supply Chain to oversee 3PL activities and deviations.

Skills

Regulatory affairs

Quality management systems

Audits & inspections

Technical report writing

Stakeholder collaboration

Education

Bachelor's degree in Science/Life sciences/Engineering

Internal auditor certification (ISO 13485)

Job description

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.