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Senior Change Management Specialist

2 weeks ago

Dublin, Dublin City, Ireland beBeeCompliance Full time €79,077 - €114,967
Job Summary

We are seeking a seasoned professional to lead the coordination of change management activities and ensure compliance with regulatory requirements.

Key Responsibilities:
  • Oversee the global change control process, including leading change review board activities (documentation, data, customer notifications, and approvals)
  • Collaborate with cross-functional teams on West change controls and provide guidance and quality consultation to change owners on change levels and associated tasks
  • Assist change owners in outlining action plans, tasks, and responsibilities to ensure timely execution of changes
  • Drive visibility and oversight of changes across the network to ensure applicability and consistency
  • Oversee assessment of change controls and assure consideration of change impact across products, platforms, life cycle phases, supply chain, and processes
  • Ensure accurate entry of change control information into relevant tracking databases
  • Provide mentoring and training to change owners on change control processes and tools

Additional Responsibilities:

  • Maintain adherence to corporate quality system requirements

Qualifications:

  • Bachelor's degree in science or equivalent experience required
  • Master's degree in science or equivalent experience preferred

Work Experience:

  • Minimum 5 years of experience in regulated quality assurance/quality control required
  • Experience with qualifications, quality risk management, quality systems such as ISO 13485, 21 CFR 820, ISO 14971, medical device product development life cycle activities, verification/validation activities, risk management, DHF activities, MasterControl, SAP, Share Point, Teamcenter preferred

Preferred Skills and Abilities:

  • Ability to work independently, multitask, and thrive in a fast-paced environment
  • Excellent critical reading and writing skills
  • Effective problem-solving and interpersonal skills

Travel Requirements:

  • Up to 13 business days per year
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