Regulatory Compliance Specialist

2 weeks ago


Manila, National Capital Region, Philippines SimplerQMS AS Full time
About the Opportunity
SimplerQMS is seeking a talented Regulatory Compliance Specialist to join our team. As a key member of our organization, you will be responsible for ensuring our software platform and related products comply with regulatory requirements. You will work closely with cross-functional teams to plan, execute, and continuously improve validations in accordance with GAMP 5, ISO/TR 80002-2, ISO 13485, FDA 21 CFR regulations, Eudralex Volume 4 GMP Annex 11, and the evolving FDA Computer Software Assurance (CSA) framework.

Key Responsibilities:
  • Stay updated on global regulations and ensure compliance.
  • Collaborate with cross-functional teams to plan and execute validations.
  • Lead documentation efforts, ensuring traceability between requirements and design specifications.


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