Regulated Manufacturing Project Coordinator

hace 2 semanas


Añasco, Puerto Rico Labchems Corp. A tiempo completo

The role of this position is to provide support to the European Union Medical Device Regulation (EU MDR) program at Labchems Corp. The successful candidate will be responsible for participating in data gathering and compilation of required documentation, conducting gap assessments on manufacturing documentation, and performing remediation tasks.

Key Responsibilities:
  • Data Gathering: Participate in the discovery and compilation of necessary documentation to be evaluated.
  • Gap Assessments: Assess all manufacturing documentation, including product device master records, process flow charts, incoming inspections, and validation plans.
  • Remediation Plan: Perform tasks identified as part of the remediation plan, including validation documentation generation and execution.
Requirements:

A Bachelor's degree in Engineering or Science is required, along with a minimum of 7-10 years of experience in validation activities and/or project management in a regulated manufacturing environment. Experience with regulatory agency guidelines for medical device manufacturers is also essential. The ideal candidate should have advanced skills in Microsoft Project, excellent verbal and written communication skills, and the ability to develop technical documentation.



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