Quality System Regulatory Affairs Specialist APJ
3 days ago
Overview
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. You'll thrive in a culture of belonging where your unique viewpoint matters. By harnessing Danaher's system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. Shape the Future with Us Leica Microsystems has a long history of shaping the future with groundbreaking optical and digital solutions, focusing on customer needs, innovation, and teamwork. Joining Leica means contributing to scientific discoveries and supporting surgeons in making critical decisions with advanced microscopes and AI-based image analysis solutions. Learn about the Danaher Business System which makes everything possible.
The Quality System Regulatory Affairs Specialist APJ 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 position reports to the Manager RA/QA Commercial Operations & EHS and is part of Global Quality Systems located in Singapore and will be an on-site role.
In this role, you will have the opportunity to:
Support the APJ functional commercial (CO) teams to maintain compliance with the QMS processes, interact with 3rd party auditors during site assessments, provide overall leadership to the functional levels, and support all regulatory and quality assurance (RA/QA) related issues at CO side.
Make recommendations for the continuous improvement of QMS processes and direct resources in support of KPIs and other metrics. Verify effectiveness of QMS by 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 positive relationships with relevant government and regulatory authorities. Support the APJ regulatory team in their 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.
Essential Requirements of the Job Include
Minimum 2–3 years proven QMS and/or RA experience in the regulated industry
International experience in problem solving, complaint handling, or equivalent
BSc degree or equivalent in science, engineering, or related field
Travel Requirements:
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 that add value to our lives. Check out our benefits at Danaher Benefits Info.
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit
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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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