RA/QA Specialist
People Profilers
Posted 16 hours ago
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 ••••@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
About People Profilers
Since our humble beginnings in 2002, People Profilers has steadily grown from strength to strength. Our expertise in providing Human Capital consultancy to our clients – universally sought after skills and expertise in just about any sector– has allowed People Profilers to leave an imprint across various industries and build a reputation for competency and expertise.
What differentiates People Profilers from every other recruiter is our unwavering commitment to building relationships with our clients- understanding exactly what our clients are after, and allowing us to match their precise needs. We deliver human capital solutions that allow organisations and their employees to succeed.
Here at People Profilers, we pride ourselves on being a one-stop human capital solutions provider for your organisation. Our innovative and relationship-focused workforce solutions have been provided across a wide range of industries.
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