Senior Regulatory Compliance Officer

hace 5 días


Alajuela, Alajuela, Costa Rica Hologic, Inc. A tiempo completo
Key Responsibilities
  1. Assess change requests of products for impact to design and determine supporting information required for implementation of changes.
  2. Review new and modified product designs for quality characteristics, including manufacturability, serviceability, testability, reliability, biocompatibility, sterility, and conformance to product requirements.
  3. Ensure that product development projects and changes to existing products are conducted in compliance with FDA Quality System Regulation, ISO 13485 Regulations, and other applicable local and international standards.


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