Post Market Surveillance Specialist - Wexford

Job DescriptionPost Market Surveillance Specialist - WexfordRef No: AM18208County Wexford, Republic of IrelandCompetitive salary Post Market Surveillance Specialist - County Wexford.In this position you will support co-ordination and management of Post Market Surveillance reports through the collection, analysis, review, trending, and reporting on product safety data to proactively identify potential adverse safety risks or performance trends. You will work with cross-functional team members to ensure compliance to the applicable regulations, standards, and company policies/procedures.As the Post Market Surveillance Specialist, you will support with maintaining compliance with global regulations, and also work closely with the different functions on site and between sites across EMEA and the US.Main responsibilities will include:Participate in Post Market Surveillance planning and reporting, by generating Post Market Surveillance reports.Extract and manipulate Post Market Surveillance data for reports.Coordinate and provide oversight in the analysis of Post Market Surveillance data.Work cross-functionally with Quality, Regulatory, Clinical Affairs, and Operations departments to fulfil data requests and deliver detailed analysis of PMS data.Identify and escalate instances when products are not achieving the intended performance and evaluate new failure modes when encountered.Develop and maintain knowledge of support systems where needed, including Master Control.Identify gaps and maintain Post Market Surveillance processes in compliance with global regulations.Participate in projects to align with corporate Quality, MDD/MDR strategies and regulatory submissions.Support responding to requests for additional information from competent authorities, registries and notified bodies.Interested applicants should have:Bachelor’s degree in engineering or similar field.Proficiency in Microsoft Office Suite and experience with manipulation of data in Excel.Strong interpersonal skills with the ability to work in a team environment and work under own initiative.Ability to provide analysis within strict timeline requirements and assuming accountability toward delivering on agreed upon commitments.Ability to create, review and coordinate reports based on established guidelines.Problem solving techniques with excellent organisational skills and attention to detail.Ability to make and present risk-based decisions.Ideally you will have:Experience in a similar Post Market Surveillance position.Medical device experience working with Class l, ll, and lll devices.Familiarity with regulations including ISO 13485, CFR 11820, ISO 14971 and EU MDR.Ability to develop and maintain dashboards using Power BI tools.Experience in technical writing and project management.