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Urgent! Regional Quality Assurance & Regulatory Affairs Manager (APAC) Job Opening In Singapore, Singapore – Now Hiring MICHAEL PAGE INTERNATIONAL PTE LTD
About Our Client
My client is a well-established global leader in wound care.
They design and manufacture advanced medical dressings, compression systems, skincare products, and related medical devices - working closely with healthcare professionals and investing heavily in R&D and clinical evidence.
Job Description
Regulatory Affairs
Collaborate with Global HQ to secure registrations for new products across multiple countries.
Ensure regulatory compliance of products in Singapore and other Asian markets.
Monitor Asia regulatory guidelines, advise HQ, and provide recommendations (e.g., stability studies, registration file requirements).
Keep QA/RA Managers in APAC updated on HQ developments such as new product launches and regulatory variations.
Build and lead a QARA community across the region, fostering strong relationships with both country teams and global functions.
Analyze regulatory requirements when entering new markets.
Coordinate regulatory filings and renewals in partnership with distributors and external partners.
Ensure submissions and product claims are fully supported by technical documentation.
Support the development, review, and implementation of regional regulatory and quality processes.
Partner with Supply Chain, Marketing, Finance, Sales, and other departments to identify risks and propose mitigation plans.
Align and communicate regulatory strategy across internal and external stakeholders.
Review labelling and marketing materials to ensure compliance with regulatory approvals.
Quality Assurance
Implement and maintain an effective Quality System aligned with ISO 13485, GMP, MDD 93/42 EEC, MDR 2017/745, and other relevant standards.
Act as Management Representative for GDPMDS and Qualified Person for the Singapore market.
Maintain and improve the Quality Management System (e.g., drafting/revising SOPs to meet evolving business needs).
Ensure Quality Systems are correctly implemented and maintained across regional offices and affiliates, driving continuous compliance improvements.
Lead self-assessments, Notified Body audits, and Health Authority inspections.
Track and report Quality KPIs to HQ in a timely manner.
Manage customer complaints, FSCA, recalls, and withdrawals.
Lead change controls, deviations, and CAPA management.
Oversee quality and regulatory aspects of non-group product development, sourcing, and supply in Asia: Conduct supplier, distributor, and subcontractor audits.
Audit manufacturing and sterilization facilities when required.
Monitor and close CAPAs.
Establish and maintain quality/regulatory agreements and technical specifications.
The Successful Applicant
Bachelor's degree holder
5-8+ years of Quality and Regulatory experience in the medical device industry.
ISO 13485 Lead Auditor certification and GMP knowledge (sterile and non-sterile medical devices) preferred.
Strong understanding of GDPMDS, ISO 13485, TGA, NMPA, PMDA, ASEAN MDD, MDSAP, EU MDD 93/42 EEC, and MDR 2017/745 requirements.
Proven experience working with stakeholders across APAC markets.
Skilled at managing multiple projects and priorities.
Experience managing teams directly or indirectly within a matrix environment.
High integrity, proactive, and collaborative with strong relationship-building skills.
Strong business partnering, communication, and stakeholder management capabilities.
Solid knowledge of regulatory frameworks and direct experience engaging with local regulatory authorities.
What's on Offer
Opportunities to work within a leading organisation in the healthcare industry.
Engaging and supportive company culture.
Professional development and career progression opportunities.
If you are passionate about quality assurance and regulatory affairs and are looking to make an impact in Singapore's healthcare retail sector, we encourage you to apply for this exciting opportunity
Contact
Hazel Choi (Lic No: R /EA no: 18S9099)
Quote job ref
JN-
Phone number
#J-18808-Ljbffr
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Unlock Your Regional Quality Potential: Insight & Career Growth Guide
Real-time Regional Quality Jobs Trends in Singapore, Singapore (Graphical Representation)
Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph below. This graph displays the job market trends for Regional Quality in Singapore, Singapore using a bar chart to represent the number of jobs available and a trend line to illustrate the trend over time. Specifically, the graph shows 4612 jobs in Singapore and 4105 jobs in Singapore. This comprehensive analysis highlights market share and opportunities for professionals in Regional Quality roles. These dynamic trends provide a better understanding of the job market landscape in these regions.
Great news! MICHAEL PAGE INTERNATIONAL PTE LTD is currently hiring and seeking a Regional Quality Assurance & Regulatory Affairs Manager (APAC) to join their team. Feel free to download the job details.
Wait no longer! Are you also interested in exploring similar jobs? Search now: Regional Quality Assurance & Regulatory Affairs Manager (APAC) Jobs Singapore.
An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at MICHAEL PAGE INTERNATIONAL PTE LTD adheres to the cultural norms as outlined by Expertini.
The fundamental ethical values are:The average salary range for a Regional Quality Assurance & Regulatory Affairs Manager (APAC) Jobs Singapore varies, but the pay scale is rated "Standard" in Singapore. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.
Key qualifications for Regional Quality Assurance & Regulatory Affairs Manager (APAC) typically include Other General and a list of qualifications and expertise as mentioned in the job specification. Be sure to check the specific job listing for detailed requirements and qualifications.
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Before the Interview:To prepare for your Regional Quality Assurance & Regulatory Affairs Manager (APAC) interview at MICHAEL PAGE INTERNATIONAL PTE LTD, research the company, understand the job requirements, and practice common interview questions.
Highlight your leadership skills, achievements, and strategic thinking abilities. Be prepared to discuss your experience with HR, including your approach to meeting targets as a team player. Additionally, review the MICHAEL PAGE INTERNATIONAL PTE LTD's products or services and be prepared to discuss how you can contribute to their success.
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