Quality System Regulatory Affairs Specialist APJ

Danaher

  • Singapore
  • Permanent
  • Full-time
  • 1 day ago
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 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 where you and your unique viewpoint matter. And 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!At Leica Microsystems, we have been shaping the future for over 175 years with groundbreaking optical and digital solutions. With a culture rooted in customer focus, innovation, and teamwork, we lead the market in microscopy, imaging, and analysis, unveiling the invisible and empowering our customers to build a better, healthier world.Joining Leica Microsystems means contributing to scientific discoveries and supporting surgeons in making critical decisions. Our advanced microscopes and AI-based image analysis solutions enable users to gain profound insights into development and engineering challenges. Here, you will work on meaningful projects alongside passionate colleagues, driving progress and pushing the boundaries of what’s possible.Learn about the 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 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 further interacting directly with 3rd party auditors during site assessments, providing overall leadership to the functional levels and support for all regulatory and quality assurance (RA/QA) related issues at CO side.
  • Make recommendations for the continuous improvement of QMS processes and directs resources in support of Key Performance Indicators (KPI) and other metrics. Responsible to 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 APJ region where required. Maintain a positive relationship with relevant government and regulatory authorities. Support the APJ regulatory team in their registration activities
  • Responsible to coordinate post market surveillance (PMS) activities like adverse event/complaint, recall/field corrective actions in cooperation with the respective Business Units. Validation of processes impacting on the QMS as needed.
The 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 equivalent
Travel Requirements:
  • 25%
It would be a plus if you also possess previous experience in:
  • 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. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at .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 .

Danaher