Quality System Regulatory Affairs Specialist APJ
4 weeks ago
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 Operations & EHS and is part of the Global Quality Systems located in Singapore and will be an on-site role.
In this role, you will have the opportunity to:- Supports the APJ functional commercial (CO) teams to maintain compliance with the QMS processes, interact with 3rd party auditors during site assessments, provide leadership to the functional levels, and support all regulatory and quality assurance (RA/QA) related issues at the CO side.
- Make recommendations for the continuous improvement of QMS processes and direct resources in support of KPIs and other metrics. Responsible to verify the effectiveness of the 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 a positive relationship with relevant government and regulatory authorities. Support the APJ regulatory team in their registration activities.
- Coordinate post-market surveillance (PMS) activities like adverse events/complaints, recalls/field corrective actions in cooperation with the respective Business Units. Validate processes impacting the QMS as needed.
- 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 equivalent.
- 25%
- 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. Our programs contribute to life beyond the job. 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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Quality System Regulatory Affairs Specialist APJ
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Singapore Danaher Life Sciences Full timeOverview 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....
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