Regulatory Compliance Expert

3 weeks ago


Bengaluru, Karnataka, India Lifelancer Full time

Job Title: Regulatory Compliance Expert

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We are looking for a Regulatory Compliance Expert to support our organization in Quality System related tasks such as certification, audits and document control. This position is part of the RA/ QA organization located in India Development Center (IDC) in Bengaluru and will be on-site with possibilities of flexible work.

You will be a part of the Quality System (QS) Team and report to the Director Quality System at HemoCue AB in Sweden. If you thrive in a multifunctional, fast-paced and supporting role and want to work to build a world-class Quality system organization, read on.

In this role, you will have the opportunity to:

  • Ensure that changes to the Quality Management System are controlled and adequately managed prior to implementation.
  • Supporting organization with Quality System expertise.
  • Coordinate Quality System activities related to certification and audits.

The essential requirements of the job include:

  • University Degree in Science or Technology.
  • 6+ years of experience from similar position and knowledge (experience or external training) of applicable standards and regulations, including but not limited to ISO 13485, Quality System Regulations for Medical Devices and risk management for medical devices (ISO 14971).
  • Proficient communication skills (verbal as well as in writing) in English.

At Danaher we bring together science, technology and operational capabilities to 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. Our global teams are pioneering what's next across Life Sciences, Diagnostics, Biotechnology and beyond.

For more information about the role, please check out the below link.

https://lifelancer.com/jobs/view/bc72323a85ce076625a6e912eb01dead

The estimated salary for this role is approximately $60,000-$80,000 per year, depending on experience.



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