Quality System Regulatory Affairs Specialist APJ

4 weeks ago

Singapore Danaher Life Sciences Full time
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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