Senior PMS Specialist

  • Reference: GY46736x
  • Job Type: Permanent
  • Location: Galway
  • Category: Engineering, Technical & Manufacturing

The Global Senior Specialist role will work with the Director, Global Post-Market Surveillance to oversee global
complaint management and post-market regulatory reporting activities for the division. This
role will report directly to the Director, Global Post-Market Surveillance.

Responsibilities:

  • Assist in the development and maintenance of global standards, policies, and procedures related to complaint
  • handling and post-market adverse event reporting in accordance with 21 CFR Part 820.198, 21 CFR Part 803, ISO
  • 13485, MEDDEV 2.12-1 and others.
  • Assist in the establishment and implementation of global complaint management and adverse event reporting
  • strategies
  • Support and/or lead recurring Initial Complaint Intake and Complaint Entity site stakeholder team meetings
  • Support site audits as necessary to ensure effective implementation of global standards and procedures related to
  • complaint management and adverse event reporting
  • Provide subject matter expert (SME) guidance to sites regarding regulations associated
  • with complaint management and adverse event reporting
  • Provide SME guidance to the development teams in support of the change management process for the global
  • complaint intake and complaint management technology solutions
  • Carry out duties in compliance with established business policies
  • Demonstrate commitment to the development, implementation and effectiveness of the division Quality
  • Management System per ISO, FDA, and other regulatory agencies
  • Responsible for exhibiting professional behavior with both internal/external business associates that reflects
  • positively on the company and is consistent with the company’s policies and practices
  • Perform other duties & projects as assigned

Skills, Experience and Qualifications:

  • Bachelor’s degree in related field (Science or engineering preferable)
  • A minimum of 8 years working in a regulated medical device complaint management function
  • Strong background in complaint management process definition and compliance discipline
  • Expert knowledge of US and global regulations related to medical device complaint handling and regulatory
  • reporting in accordance with 21 CFR Part 820.198, 21 CFR Part 803, ISO 13485, MEDDEV 2.12-1 and others.
  • Experience working in electronic complaint management systems
  • Excellent verbal and written communication skills, able to convey appropriate information with clarity and
  • effectiveness.
  • Excellent computer skills including all MS Office applications
  • Able to travel internationally (approximately 10% annually)
  • Experience supporting in-vitro diagnostics products
  • Experience managing a global complaint handling functional group for medical device or in-vitro diagnostics

For a confidential discussion and more information on the role/company please  email your CV to: amy.oneill@collinsmcnicholas.ie


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Amy O’Neill

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  • Amy O’Neill
  • Recruitment Consultant
  • 091706718
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