Quality System Regulatory Affairs Specialist APJ
2 days ago
Overview Quality System Regulatory Affairs Specialist APJ role at Leica Microsystems, a Danaher operating company. The position is responsible for maintaining the existing Quality Management System (QMS) according to standards (ISO13485, ISO9001, ISO14001) and applicable regulatory requirements for Leica Microsystems Commercial Offices in the APJ region. This is an on-site role reporting to the Manager RA/QA Commercial Operations & EHS and located in Singapore as part of Global Quality Systems. In This Role, You Will Have The Opportunity To Lead and support APJ functional commercial (CO) teams to maintain QMS process compliance. Interact with 3rd party auditors during site assessments. Provide leadership and support for all regulatory and quality assurance (RA/QA) issues at the CO side. Drive continuous improvement of QMS processes and monitor KPIs and other metrics. Verify QMS effectiveness through internal audits. Manage the QMS platform for the creation of quality documents and trainings. Coordinate product registration activities in the APJ region and maintain positive relationships with government and regulatory authorities. Support the APJ regulatory team in registration activities. Coordinate post-market surveillance (PMS) activities such as adverse events/complaints, recalls/field corrective actions in cooperation with the respective Business Units. Validate processes impacting the QMS as needed. Responsibilities Supports the APJ functional commercial (CO) teams to maintain compliance with QMS processes and interact with 3rd party auditors during site assessments; provide leadership and support for RA/QA issues at CO side. Make recommendations for continuous improvement of QMS processes; direct resources in support of KPIs and metrics; verify effectiveness of QMS via internal audits. Manage the QMS platform for creation of quality documents and quality trainings. Responsible for product registration activities in the APJ region where required; maintain relationships with relevant government and regulatory authorities; support APJ regulatory team in registration activities. Coordinate post-market surveillance activities (adverse events/complaints, recalls/field actions) with Business Units; validate processes impacting the QMS as needed. Essential Requirements Minimum 2–3 years of proven QMS and/or RA experience in a regulated industry. International experience in problem solving, complaint handling or equivalent. BSc degree or equivalent in science, engineering or related field. Travel Approximately 25%Preferred/Additional Experience Knowledge of Australian medical device regulatory requirements (preferred). Knowledge of APJ region regulatory requirements (preferred). Leica Microsystems, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs. For more information, visit #J-18808-Ljbffr
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Quality System Regulatory Affairs Specialist APJ
4 weeks ago
Singapore Leica Microsystems Full timeOverview Quality System Regulatory Affairs Specialist APJ Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Leica Microsystems, one of Danaher's 15+ operating companies, our work saves lives and we are united by a shared commitment to innovate for tangible impact....
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Quality System Regulatory Affairs Specialist APJ
4 weeks ago
Singapore Fcld Full timeOverview Quality System Regulatory Affairs Specialist APJ at Leica Microsystems. The role is to maintain the existing Quality Management System (QMS) according to standards (ISO13485, ISO9001, ISO14001) and applicable regulatory requirements for Leica Microsystems Commercial Offices in the APJ region. This position reports to the Manager RA/QA Commercial...
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Singapore Danaher Corporation Full timeOverview Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?At Leica Microsystems, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of...
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Quality System Regulatory Affairs Specialist APJ
4 weeks ago
Singapore Danaher Corporation Full timeOverview Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Leica Microsystems, one of Danaher's 15+ operating companies, our work saves lives—and we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging...
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Quality and Regulatory Affairs Specialist
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Singapore Majeton Pte. Ltd. Full timeOverview At Majeton, we are driven by our commitment to deliver “The Right Product for Health”. Our team of researchers and clinical experts utilize clinic feedback from practitioners, scientifically researched literature and top quality manufacturing as the foundation for all products. We are seeking a meticulous and experienced Quality & Regulatory...
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Regulatory Affairs Specialist
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Singapore Johnson & Johnson Full timeJohnson & Johnson is currently seeking a Regulatory Affairs Specialist to join our Regulatory Affairs team located in Singapore. : The Regulatory Affairs Specialist is a member of the Local Operating Company (LOC) Regulatory Affairs team and is responsible for preparation of life cycle management submissions to the Health Authority. Globally dispatched life...
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Regulatory Affairs Specialist
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Singapore Johnson & Johnson Full timeThe Regulatory Affairs Specialist (MD) is a member of the local Regulatory Affairs department, responsible for activities to support and actively contributing to the regulatory compliance of medical devices products under their responsibility. - The Regulatory Affairs Specialist (MD) will be a member of the local regulatory affairs department within Johnson...
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Singapore ALCOTECH PTE. LTD. Full timeAlcotech Pte Ltd specializes in Infectious Disease Kits and Medical Device Regulatory Affairs. We support medical device manufacturers in navigating complex regulatory landscapes and securing market access across Singapore and Southeast Asia. Role Overview We are seeking a Regulatory Affairs Specialist with either experience working at the Health Sciences...
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Regulatory Affairs Specialist
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Singapore ALCOTECH PTE. LTD. Full time $49,300 - $63,500 per yearAlcotech Pte Ltd specializes in Infectious Disease Kits and Medical Device Regulatory Affairs. We support medical device manufacturers in navigating complex regulatory landscapes and securing market access across Singapore and Southeast Asia.Role OverviewWe are seeking a Regulatory Affairs Specialist with either experience working at the Health Sciences...
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Regional Regulatory Affairs Specialist
3 hours ago
Singapore Reeracoen Singapore Pte Ltd Full timeJob title: Regional Regulatory Affairs Specialist Our client, a Japanese pharmaceutical company, is currently seeking to hire a Regional Regulatory Affairs Specialist to support operations across Asia and the ASEAN region. The primary responsibilities of this role include coordinating regulatory submissions, supporting strategy development, and monitoring...
