Corrections & Removals Specialist

Philjobs

Onsite
Correction and removal file documentation
Product recalls and field actions
Regulatory requirements and compliance
Philips is seeking a Corrections & Removals Specialist to coordinate the documentation and execution of product corrections and removals while ensuring compliance with regulatory standards. The role requires extensive experience in the healthcare or medical device sectors, emphasizing performance monitoring, regulatory compliance, and effective communication

Job Summary

  • Coordinates the creation and completion of correction and removal (C&R) file documentation and ensures comprehensive C&R file preparation and timely responses to correction and removal requirements.
  • Reviews and submits relevant communication to the appropriate competent authorities or regulatory agencies, as per the regulatory requirements of the respective country or market, and conveys vital information related to product safety concerns and risk mitigation strategies.
  • Implements corrective actions, executes necessary improvements, maintains awareness of customer feedback and incorporates insights into corrective action plans to ensure continuous enhancement.

Matching Summary

Match Score: 85

Philips is seeking a Corrections & Removals Specialist to coordinate the documentation and execution of product corrections and removals while ensuring compliance with regulatory standards. The role requires extensive experience in the healthcare or medical device sectors, emphasizing performance monitoring, regulatory compliance, and effective communication.

Skills & Requirements

Must-have

  • Correction and removal file documentation
  • Product recalls and field actions
  • Regulatory requirements and compliance
  • Product safety concerns and risk mitigation
  • Analyze product complaints and adverse events

Nice-to-have

  • Quality Management Systems (QMS)
  • Root Cause Analysis (RCA)
  • CAPA Methodologies
  • Business Acumen
  • Continuous enhancement of processes

Key Requirements

  • Bachelor's Degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management or equivalent
  • 4 years of experience in Pharma, IVD, Medical Device, Quality Assurance, Quality Control, Clinical Research or equivalent with Vocational Education

Work Rights

Not specified

Tailored Resume

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