Regulatory Affairs Specialist

1 month ago

Singapore Danaher Full time

Wondering whatâs within Beckman Coulter Diagnostics? Take a closer look.

At first glance, youâll see that for more than 80 years weâve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. Weâre building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and youâll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.

Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, weâre working at the pace of change to improve patient lives with diagnostic tools that address the worldâs biggest health challenges. 

The Regulatory Affairs Specialist for Beckman Coulter Diagnostics is responsible for managing registration activities of products distributed by Beckman Coulter Singapore, ensuring that regulatory projects are completed within projected timelines. 

This position is part of the Quality and Regulatory Affairs located in Singapore and will be in hybrid working environment. In QRA team, our vision is to enable business via fast submission and approvals in the responsible countries thereby allowing early access to Beckman Coulter products for the patients.

You will be a part of the QRA Team and report to the QRA Senior Specialist responsible for SEA-South. If you thrive in a fast-paced role and want to work to build a world-class Quality and Regulatory organizationâread on.

In this role, you will have the opportunity to:

  • Ensure on-time product registrations (new and change notification) by preparing documents and dossier.
  • Ensure all technical documents are updated and ready for regulatory submission.
  • Handling regulatory matters with Singapore HSA.
  • Report Field Safety Correction Action (FSCA) and adverse events to HSA if needed.
  • Ensures compliance with local regulations, corporate policies and procedures.

The essential requirements of the job include:

  • Minimum Degree in sciences, engineering or related fields.
  • Minimum of 2 years relevant experience in regulatory affairs. 
  • Great interpersonal and communication skills.
  • Able to work independently and a team player.

It would be a plus if you also possess previous experience in:

  • Registrations in Singapore for medical devices and/or IVDs.

Danaher is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why weâll empower you to push the boundaries of whatâs possible.

At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrowâs 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. Our global teams are pioneering whatâs next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

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