Post Market Surveillance Specialist

  • Enniscorthy
  • Bd
Job DescriptionWe are the makers of possibleBD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.Why join us? A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.Become a maker of possible with us!Our vision for Peripheral Interventionat BDOur Peripheral Intervention (PI) business unit offers a comprehensive range of medical products, devices and services for the treatment of peripheral arterial and venous disease, cancer detection, and end-stage renal disease and maintenance.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 BD Quality, MDD/MDR strategies and regulatory submissions.Support responding to requests for additional information from competent authorities, registries and notified bodies.About you:Bachelor’s degree in Engineering or similar field is essential.Proficient 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.The following skills are not essential but a distinct advantage: Experience in a similar Quality 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.Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.Primary Work LocationIRL Wexford - EnniscorthyAdditional LocationsWork Shift