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Regulatory Affairs & Quality Manager

Regulatory Affairs & Quality Manager Our client a cardiovascular medical device start-up looking to hire a Quality and Regulatory Affairs manager. The succ

Location: Dublin,
Regulatory Affairs & Quality Manager 		Dublin Not Disclosed
Other Quality Assurance Jobs
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QA Technical Support Specialist Dublin Not Disclosed
Quality Compliance Specialist Australia Not Disclosed
QA Executive Galway Not Disclosed
QA Specialist - MES Limerick Not Disclosed
Senior GMP Auditor Limerick Not Disclosed
QA Specialist-Batch Release Limerick Not Disclosed
Quality Compliance Specialist Australia Not Disclosed
Quality Compliance Specialist Australia Not Disclosed
Quality Compliance Specialist Australia Not Disclosed
Senior Director Operational Strategy Dublin Not Disclosed
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Quality Director Career Profile

Quality Director


Director of Quality is typically responsible for all quality realted issues on site, this includes all company procedures and data used and ensuring they remain compliant to ISO 13485 standards or other acceptable quality standards.

Role/Responsibilities

  • Provides direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments.
  • May supervise non-exempt employees
  • Keeps the organization's vision and values at the forefront of decision making and action
  • Demonstrates effective change leadership
  • Builds strategic partnerships to further departmental and organizational objectives
  • Develops and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills
  • Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations, etc.)
  • Makes decisions regarding work processes or operational plans and schedules in order to achieve department objectives
  • Develops, monitors and appropriately adjusts the annual budget for department(s)
  • Develops, formulates, and directs quality control programs involving specialized or advanced inspection methods, devices, and control techniques
  • Approves documents defining the Quality System
  • Reviews subcontractor's Quality System to ensure that purchased product fully complies with the specified

Skill/Experience

  • Bachelor's Degree in a related Discipline
  • 10+ years experience working within a regulated manufacturing environment
  • Previous supervisory/management experience essential