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  • Description



  • JOB DESCRIPTION:

    • Perform high-volume end-to-end complaint handling activities, including, but not limited to: Intake, triage and review of the event reported, determination of MDR reportability, recovery of field samples for evaluation, determination of Priority/Non-Priority, and QP notification to LOC. Additional activities include due diligence to be performed with the complainant/intake centers/LOC, trend analysis, defect coding, risk criticality assessment, ensuring accurate/holistic investigation, and review and closure.

    • Perform MDR evaluations and document written justification to support reportable and non-reportable regulatory decisions.

    • Monitor complaints for new malfunction events that may require inclusion in the malfunction description list.

    • Ensure uniform and timely management of complaint and MDR records from receipt to closure.

    • Ensure investigations are accurately assessed for risk prioritization and performed per procedures, standards, and regulations.

    QUALIFICATIONS:

    • 3-5 years of related experience including Quality Assurance and/or Quality Control, including experience working in pharmaceutical and/or Medical Device or other related highly regulated industry.

    • Knowledge of medical safety environment and regulation.

    • Global mindset and demonstrated ability for change initiatives, project management and develop strong relationships working knowledge of and experience with the following regulatory requirementsM

    • Willing to work in Paranaque

    • CAN START ASAP!

    For faster application, please send your resume at ****@collabera.com or contact (Click "apply now to" see contact details)/ (Click "apply now to" see contact details)

  • Requirements

  • Minimum education level: Bachelor´s Degree
  • Years of experience: 5
  • Language(s): English
  • Availability for travel: No
  • Availability for change of residence: No
To see the complete contact information, Apply now

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Job summary

  • Regulatory Pharmacist (WFH) 50K

  • Parañaque, National Capital Region

  • Company

    Collabera Technologies Private Limited, Inc
  • Type of contract

    Permanent contract

  • Work type

    Full Time

  • Salary

    ₱ 50,000.00 monthly

  • Apply