Senior Post Market Surveillance Specialist

JOB PURPOSE
The successful candidate will act as the primary contact for registering confidential complaints and/or product dissatisfaction. They will receive, answer and document customer complaints, telephone or written, on all products and maintain complaint information in line with regulatory requirements.

KEY RESPONSIBILITES
• Key responsibilities will include (but are not limited to) the following:
• Receive and log product complaints from a variety of sources.
• Document and coordinate the investigation of product performance issues
• Coordinate and/or perform complaint investigation, ensure related follow-up activities and document investigation findings and results
• Provide support on failure evaluation of returned products.
• Follow up on outstanding evaluations to ensure timeliness and regulatory compliance.
• Support Adverse Event Reporting Regulatory Requirements
• Under limited supervision draft responses to specific product complaint and vigilance report queries from Competent Authorities.
• Monitor customer complaints and provide immediate feedback to concerned personnel when critical issue is detected.
• Maintain complaint tracking system
• Prepare complaint trending reports
• Attend/facilitate meetings to resolve Customer Complaints
• Ensure effective CAPA is taken to help prevent reoccurrence • Coach/Mentor team members, imparting learning and knowledge
• Oversee regulatory and corporate deadlines
• Ensuring that any Recall strategy provided by a Legal Manufacturer is complied with
• Ensuring appropriate recall activities are documented, approved and communicated to relevant parties
• Consignee List coordination and circulation
• Preparation and obtaining approval of Field Safety Notices, Field Safety Corrective Action Forms in conjunction with the Coordinating Competent Authorities along with Management.
• Coordination of the issue of the Field Notice and reconciliation of Acknowledgement status from consignees.

ESSENTIAL SKILLS / EXPERIENCE
• Engineering/Science qualification with 2/3 years of working within complaints in a medical device environment.
• 2/3 years’ experience in vigilance reporting or other equivalent regulated environment Excellent technical writing experience within a medical device environment – essential
• Good knowledge of the Medical Device Directive and familiarity with its transposition into national legislations within Europe as it affects post market surveillance
• Good working knowledge of the Quality System Regulations as they pertain to customer complaints




Clodagh Nerney | Tel: +353 (0) 1 507 9254