Graduate, Regulatory Affairs

Overview The opportunityGet started on an exciting and meaningful career path with Cook Medical. We love passionate people with great ideas. Our 18-month graduate program in Limerick, Ireland provides tailored opportunities to use your qualifications and launch your career while learning and developing new skills.About Cook MedicalSince 1963, Cook Medical has been finding solutions to improve the world’s healthcare problems for the patients and doctors we serve. As the world’s largest privately owned medical device company, we have always operated with our patients, customers, employees and communities at our core. We do this, not only because it is good business, but also because we believe that exemplary patient care and being a good corporate citizen is the right thing to do.Cook Medical has been in Limerick since 1996. Since opening, we have become a European headquarters for many of Cook’s business functions.With a global workforce of over 12,000, we employ over 950 people in Ireland who bring Endoscopy, Urology and Peripheral Intervention products from conception to commercialisation.Position: Graduate, Regulatory AffairsReporting to: Team Lead / Manager Regulatory Affairs Responsibilities As a Regulatory Affairs graduate you will gain hands-on experience and knowledge as well as having responsibilities in the following areas: -Regulatory requirements in accordance with ISO13485, EU Medical Device Regulation 2017/745 and FDA QSP 21CFR Part 820 as required.Opportunity to join a world leading medical device company and gain the foundations necessary to be a future Regulatory leader by working with multiple regulatory teams including Clinical & Post Market Surveillance, Device Compliance & New Product Introductions.Cross functional exposure both on site and with global teams.Maintains registration information (license numbers, expiration dates etc) and obtains re-registration approvals in advance of license expirations to ensure no disruption in product availability.Provides regulatory support to Cook functional units such as the SSC, tenders, customer quality and distribution.Develop knowledge of clinical requirements required to support market authorisations.Provides hands-on experience in the rapidly growing field of Regulatory Affairs.Gain exposure to Premarket Regulatory Strategy, International Regulatory Affairs, Biocompatibility, Preparation of Submission Packages and Post Market Surveillance.Become part of a diverse team to bring new products to patients and maintain existing products on the market.Gain knowledge and experience leading to professional and personal development.Ensure that Cooks Code of Conduct is considered in all business matters carried out on Cook’s behalf. Qualifications Third Level qualification in Science, Engineering or a relevant technical discipline. Previous experience in medical device roles is desirable but not essential.Ambitious, passionate and dynamic individual with a high level of integrity, drive and commitment.A genuine interest in quality and regulatory aspects of the medical device industry. Strong work ethic.Highly motivated individual, self-starter with a passion for excellence.Excellent communication skills, both oral and written.Basic knowledge of medical device quality standards/practises or similar regulated industry is desired.Proven problem-solving skills.Good computer skills including knowledge of Microsoft Office.Proven organisational skills.Attention to detail and quality focus.Team Player with ability to develop strong working relationships.Our employee benefits include: Competitive annual salary Quarterly Cook Rewards Teamwork bonus program Educational Assistance - access to training programsSports & Social clubCompany sponsored Defined Contribution pension scheme Medical Health Insurance cover for you and your immediate family Life Assurance and Income Protection cover Extensive health & wellness program including Indian head massages, healthy lifestyle seminars, mindfulness courses, physio sessions, flu vaccinations, nutrition talks Fully equipped gym on site 39-hour week with flexible start & finish times Paid time off to participate in volunteer activities Free parking Subsidised restaurant #LI-Hybrid