About the role
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 ashley@peopleprofilers.com
We regret that only shortlisted candidates will be notified
People Profilers Pte Ltd
Tel**: [6950 9753](tel:6950 9753)**
EA Registration Number: R1111375
EA licence number 02C4944
EA Personnel: Lee Hui En Ashley
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