**FIXED TERM CONTRACT** **Abbott in Ireland** Abbott serves the Irish market with a diverse range of healthcare products, including diagnostics, medical devices, and nutritional products. In Ireland, Abbott employs over 6,000 people across ten sites. We have seven manufacturing facilities located in Clonmel, Cootehill, Donegal, Kilkenny, Longford, and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations, and shared services in Dublin and Galway. We have been operating in Ireland since 1946. **Abbott Nutrition** Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, Glucerna® and ZonePerfect® – to help get the nutrients they need to live their healthiest life. **PURPOSE OF THE JOB** As a Medical Safety & Surveillance (MSS) Global Medical Device Manager, the candidate will use his/her in-depth understanding of medical devices to ensure compliance with regulatory requirements for Abbott Nutrition medical devices. The MSS Global Medical Device Manager will have responsibility for generating documentation that supports Abbott Nutrition’s global medical device registration and on-going compliance with EUMDR. This may include development and implementation of global standardized operating procedures. The candidate may also lead the development/maintenance of local medical device vigilance systems (predominantly for UK and EU), ensuring compliance with local regulations. The candidate will have departmental, cross functional, and global influence, and will be considered a medical device subject matter expert within the company. **MAJOR RESPONSIBILITIES** + Organizes, manages and maintains a highly compliant global medical device system for Abbott Nutrition. + Maintains awareness and ensures compliance with established and updated local and global medical device processes as well as local and global regulations and guidelines for medical device registration and post-market documentation. + Develops and implements training programs for individuals involved in medical device activities. + Monitors medical device system performance; tracks compliance metrics and reports to global MSS Leadership Team. + Ensures global/local medical device audit readiness; Supports medical device audits/inspections and leads activities related to corrective and preventative actions for any audit findings. + Actively contributes to activities related to the monitoring of safety profiles for Abbott Nutrition products registered as medical devices, such as signal detection, evaluation, and prioritization. + Reviews and provides input to product DFMEAs. + Assists local staff with drafting and implementation of Safety Data Exchange Agreements, if applicable. + Works cross-functionally with Regulatory Affairs and Quality Assurance functions to maintain current knowledge of regulatory safety reporting guidelines and implementing relevant guidelines into practices and procedures. + Assists in the preparation, review and submission of aggregate safety reports. + Accountable for strategic preparation of medical device regulatory submission documentation (i.e. CEP, CER, PSUR, PMCF etc) and on-time completion of these activities for the division. **EDUCATION & COMPETENCIES** + Master’s degree in related health science or equivalent skills, education, or experience. + RAC certification is a plus. + 5-7 years of experience and proficiency in medical device regulatory submissions to Notified Bodies under EUMDR / MedDEV and knowledge of Medical Device standards and guidelines (such as ISO, GSPR, and MDGC). + Solid understanding and working knowledge of medical device regulatory requirements and in the development and implementation of processes to maintain compliance. + Strong medical knowledge and understanding to support safety related activities; background/experience with nutrition/nutritional products is a plus. + Knowledge of Vigilance reporting regulations on a Global scale. + Minimum 3 years of experience in leading complex projects or programs; global/regional experience desirable. + Fluency in spoken/written English; + Computer proficient (Windows, Word, Excel); experience working in adverse event databases. + Excellent communication and interpersonal skills, both written and spoken. + Strong organizational skills with proven ability to prioritize and work on multiple tasks and projects. + Strong commitment to compliance with the relevant rules and procedures and to scientific quality and integrity. + High level of accountability and reliability. + Demonstrates ability to work productively as a team. + Ability to work in a fast paced, changing environment. + Ease of operating in high stress, big decision situations. + Continuous improvement mindset. + Ability to influence a team in a positive way in relation to performance, change, and culture. + Demonstrate broad knowledge of Abbott’s business and how department processes/responsibilities interconnect. + Mastery of the inventory deployment planning process. + Exceptional problem-solving skills An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com