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Senior Post Market Surveillance Specialist

Job description

Senior Post Market Surveillance Specialist

Work within one of the largest diagnostics and medical analytical equipment companies globally in their growing Galway site. Act as Senior SME onsite for post market surveillance and customer or patient related issues. You will work on ensuring all business units are aware of relevant regulatory obligations.

Responsibilities: 

  • Manage global quality information and data analysis for the PMS team and ensure proper application to ensure greater quality assurance when it comes to patients and customers
  • Maintain global QMS for PMS, ensuring continuous improvement for processes and protocols
  • Ensure compliance to corporate and regulatory requirements
  • Escalation point for quality related NCRs and CAPAs
  • Support the development of direct reports through ongoing mentoring and coaching
  • Manage risk assessments based on global data from product performance reports and complaints
  • Travel to other sites (Up to 15%) to work on continuous improvement projects

 Requirements: 

  • Level 8 degree in Science or Engineering with 6 years or more experience working within the medical device industry
  • Must have working knowledge of Global Medical Device regulations (e.g. ISO9001/ ISO13485/ ISO14971/ cGMP / CE/ FDA/ PAL/IVDR/MDSAP)

 

To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E:   jporter@sigmar.ie  

All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent

 

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