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Urgent! Quality System Regulatory Affairs Specialist APJ Job Opening In Singapore, Singapore – Now Hiring Danaher Life Sciences
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
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Unlock Your Quality System Potential: Insight & Career Growth Guide
Real-time Quality System 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 Quality System 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 4085 jobs in Singapore and 3520 jobs in Singapore. This comprehensive analysis highlights market share and opportunities for professionals in Quality System roles. These dynamic trends provide a better understanding of the job market landscape in these regions.
Great news! Danaher Life Sciences is currently hiring and seeking a Quality System Regulatory Affairs Specialist APJ to join their team. Feel free to download the job details.
Wait no longer! Are you also interested in exploring similar jobs? Search now: Quality System Regulatory Affairs Specialist APJ 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 Danaher Life Sciences adheres to the cultural norms as outlined by Expertini.
The fundamental ethical values are:The average salary range for a Quality System Regulatory Affairs Specialist APJ 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 Quality System Regulatory Affairs Specialist APJ 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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