Regulatory Compliance Manager

7 days ago


Kuala Lumpur, Kuala Lumpur, Malaysia Cochlear Full time

Cochlear is a global leader in implantable hearing solutions, seeking a highly skilled Regulatory Compliance Manager to join our team. As a key member of our Quality Management System (QMS), you will be responsible for ensuring regulatory compliance across our products and services.

In this role, you will work closely with cross-functional teams to identify and mitigate risks, develop and implement compliance strategies, and maintain records of compliance activities. You will also conduct internal audits and manage external audits to ensure we meet regulatory requirements.

Your Key Responsibilities Will Include:

  • Develop and implement compliance strategies to ensure regulatory compliance across our QMS and products.
  • Conduct internal audits and manage external audits to ensure we meet regulatory requirements.
  • Maintain accurate records of compliance activities and submit reports as required.

You Will Need:

  • Bachelor's degree in a relevant field, such as Engineering, Science, or Business.
  • Minimum 5 years of experience in a quality assurance or regulatory compliance role.
  • Strong knowledge of FDA 21 CFR Part 820 and EN ISO 13485 regulations.


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