Senior Management Accountant

Senior Quality Engineer Post Market Surveillance

About Aerogen: Headquartered in the vibrant city of Galway, with offices around the world, Aerogen is proud to be the world leader in acute care aerosol drug delivery. Recognised through multiple MedTech awards and eight-time winner of the Zenith award for Respiratory Care Excellence in North America, collectively our employees make a difference to patients’ lives every day, having already reached 16 million patients in over 75 countries. Our talented and skilled team collaborate to innovate, challenge and test not only in relation to our products but every facet of how we work. We lead the way, finding innovative solutions to even the most complex problems, all in the name of delivering better patient care. Our business is growing rapidly across the globe and as we grow, our core culture of “We Care” universally connects us. We believe that your ambition and integrity fuels ours and we are committed to supporting our employees to reach their full potential through tangible investment in their careers. Join us as we continue to #discoverbetter.  What is the role? Manage key elements of the Quality System to ensure compliance to relevant standards for the business including EN ISO13485:2016, MDSAP, FDA and EU MDR requirements. The role will take the lead in ensuring that the quality system is maintained and implemented in a compliant manner and areas of improvement are identified and implemented as required. This will involve coordinating and working with all functions in a collaborative manner. What are the key responsibilities? •Manage and direct the complaints team to ensure that complaint handling, investigating, and vigilance reporting requirements are achieved. •Responsible for the site complaint and Vigilance KPIs, •Manage review, submission and follow ups for MDR, EU and worldwide vigilance reporting to the external regulatory agencies. •Identify and initiate action to address any complaints adverse trends or regulatory compliance issues. •Support Design Assurance in risk management, risk analysis and health hazard analysis associated with complaint/post market information. •Support Clinical Affairs in relation to complaint/post market information. •Ensure adequate support of complaint trend analysis and annual post market surveillance reports for various products. •Participate in customer and notified body audits. •Participate in internal audits as per the Internal audit schedule. •Manage all Non-Conformances and CAPA specifically linked to the complaints team. •Implement continuous improvement activities. •Other project work as assigned by the Manager. What education and experience are required? •A degree in Engineering, Technology, or Science •At least 8 years’ experience working in a regulated medical device or pharmaceutical company. •Excellent planning and coordination skills. •Excellent verbal and written communication skills. •Excellent attention to detail skills. What key skills will make you great at the role? •Ability to work within a team environment to achieve agreed company goals. •Ability to communicate quality / regulatory concepts effectively. •Excellent understanding of EN ISO 13485:2016, MDSAP, FDA and EU MDR regulations. •Experience in reporting Adverse events to Regulatory bodies •Formal Audit Training •Proficiency in use of desktop software applications such as MS office. •Some travel may be required with the role. What is it like to work at Aerogen? Our purpose is to transform patient lives and our ethos is to #discoverbetter. This also translates to how we look after our people. We want talented, passionate and engaged people to join Aerogen and build your career with us. We understand that your life evolves through different stages, and we are here to support our global team with a range of financial and non-financial rewards and benefits. There’s something for everyone! Here is an idea of what we offer: •Excellent medical care. •Bonus & Pension. •‘Aerogen Connect’ – our employee led programme which supports our global teams to unite and have fun. •We pledge 1% of profits and time to charities and organisations. Check out our careers website to discover more about Life at Aerogen Aerogen is committed to promoting diversity, inclusion and equality in the workplace. If you have any difficulty using our application process, please contact us by emailing careers@aerogen.com. Please include your name and preferred method of contact. Job Title Senior Quality Engineer Post Market Surveillance Product approvals and set ups may vary by country. Always refer to the user instructions suppliedwith the product for full set up instructions, warnings, cautions andcontraindications. #J-18808-Ljbffr