Mgr QARA Regional

Requirements

• Bac

Benefits

Additional Information

Medline - Together, Advancing Healthcare Medline is a healthcare company-a manufacturer, distributor and so much more, doing business in more than 125 countries and territories around the world. We provide the quality medical products and solutions our customers need to deliver their best care to every person in every care setting. Medline is committed to reducing our carbon footprint, developing responsible products, supporting our employees and local communities, and promoting high ethical standards internally and among our supplier partners. Click here to discover what Medline is doing to make healthcare more sustainable for people and the planet. Job Summary The Regulatory Affairs & Quality Manager leads all regulatory and quality activities across Southeast Asia region (Malaysia, Singapore, Thailand and Taiwan) for hospital consumables (Class I-III) and cosmetics. The role ensures end-to-end product compliance, including registration, license maintenance, post-market surveillance, and QMS oversight. Reporting to the General Manager, AEM, the role manages a team of two and acts as the regional expert for regulatory and quality matters, working closely with distributors and internal stakeholders and RA agents. This position is accountable for executing Medline's regulatory and quality strategy in the region, driving compliance, consistency, and continuous improvement. Job Description Regulatory Affairs: Prepare and submit product registration and renewal documentation to support registration with respective local authorities in AEM via distributors and RA agents. Liaise with Corporate offices, internal departments and manufacturing sites to obtain the documentation required. Ensure submissions are complete, properly formatted and compliant with regulatory requirements and enable timely approvals. Review and assess changes in existing products for new registration and/or license revisions. Work with cross-functional teams to assess and minimize impact on existing business. Notify and update relevant changes to product registrations and regulatory requirements. Lead the coordination of adverse events (AE) and Field Safety Corrective Action (FSCA) reporting activities, collaborating with corporate teams, distributors, and regulatory consultants to ensure regulatory compliance and timely submission to local health authorities. Maintain product licenses approvals and update Corporate on product listing database. Maintain all product registration submission dossiers in Regional HQ. Review and approve all labels, advertising material to ensure compliance with approved claims and regulatory standards. Ensure labels used by 3PL warehouses are correct and up to date. Monitor new regulatory requirements and provide regulatory intelligence for impact assessment and update regional RA. Support ad hoc requests from distributors/ sales on product information (e.g., technical datasheets). Quality Management System: Maintain the continuous effectiveness of the Quality Management System of Medline Singapore. Ensure SOPs are aligned with Medline Corporate and Regional Quality Management System. Establish or improve existing procedures and align with corporate offices. Perform internal audits for self-assessments, at 3PL warehouse and distributors to ensure control of the distribution process. To facilitate inspections and audits from regulatory bodies or notified bodies. Liaise with internal and external stakeholders to ensure that product complaints and issues are responded to in a timely manner and that the relevant communication is forwarded onto customers Identify improvements and inputs into the quality planning process. To support ad hoc requests from distributors/ sales on product information (e.g: technical datasheet, vendor information). Quality Activities: Receive product quality complaints from distributors/ end users in Southeast Asia, collaborate with Corporate complaint handling team for investigation and resolutions and ensure credit notes are issued to distributors. Work with local Supply Chain to ensure incoming inspections are conducted in 3PL warehouse. Work with local Supply Chain to ensure any deviation/ reworks activities performed by 3PL warehouse are in accordance with regional procedures and review the deviation/ rework performed. Global Quality & Regulatory Collaboration: Work closely with the QARA team in the US to ensure regional QARA activities are aligned with global standards, processes and expectations. Attend and actively participate in the annual QARA conference to stay aligned with global quality and regulatory priorities. Provide Asia Emerging Markets updates, including key regulatory changes, submission progress, quality matters and market challenges. Share regional insights and best practices to support continuous improvement across the global QARA function. Support the implementation of global QARA initiatives, policies and processes across Asia Emerging Markets.

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