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Change Control Specialist

1 week ago

Manila, National Capital Region, Philippines iRhythm Technologies, Inc. Full time

iRhythm GBS Philippines is committed to providing an exciting career path for every team member.

Job Description:

This role is responsible for owning and leading the change control process to support engineering changes, ensuring compliance with regulatory requirements. The ideal candidate will have strong communication and interpersonal skills, with attention to detail and timeliness being critical.

  • Responsible for document redlines based on engineering inputs.
  • Document change impact assessments, risk assessments, documenting change descriptions, and other administrative change control steps based on engineering inputs.
Required Skills and Qualifications:

The successful candidate will possess a Bachelor's Degree or equivalent experience, with a minimum of 2 years of experience in Document Management System. They will also have thorough understanding of the regulations and regulatory processes for document control/management.

  • Strong technical writing skills with the capability to update documents based on inputs from engineering.
  • Previous MasterControl experience is highly desirable.
  • Experience in cGMP/GDP/GCP environments and FDA regulated industries is preferred.
Benefits:

iRhythm GBS Philippines offers a comprehensive health and life insurance benefits package, with eligible dependent coverage, as well as a competitive compensation package and above industry standard paid leave benefits.