Contact: Jenny Dore
Telephone: 086 0449371
Senior Specialist, Global Post Market Surveillance
Our client, a medical device company in Galway are currently looking to recruit a Post Market Surveillance Senior Specialist for their site.
What will I be doing
- 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 Diagnostics division. This role will report directly to the Director, Global Post-Market Surveillance.
- 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 Diagnostics 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
What do I need
- 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
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