FIXED TERM CONTRACTAbbott in IrelandAbbott 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, along with a third-party manufacturing management operation in Sligo. Abbott also has commercial, support operations, and shared services in Dublin and Galway. We have been operating in Ireland since 1946.Abbott NutritionOur 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 worldwide rely on our leading brands – including Similac, PediaSure, Pedialyte, Ensure, Glucerna, and ZonePerfect – to help meet their nutritional needs and live their healthiest lives.PURPOSE OF THE JOBAs a Medical Safety & Surveillance (MSS) Global Medical Device Manager, the candidate will leverage their in-depth understanding of medical devices to ensure compliance with regulatory requirements for Abbott Nutrition medical devices. Responsibilities include generating documentation to support Abbott Nutrition’s global medical device registration and ongoing compliance with EUMDR. This may involve developing and implementing global standardized operating procedures. The candidate may also lead the development and maintenance of local medical device vigilance systems (primarily for UK and EU), ensuring adherence to local regulations. The role involves departmental, cross-functional, and global influence, establishing the candidate as a medical device subject matter expert within the company.Major ResponsibilitiesOrganize, manage, and maintain a highly compliant global medical device system for Abbott Nutrition.Ensure compliance with established and updated local and global medical device processes, regulations, and guidelines for registration and post-market documentation.Develop and implement training programs for personnel involved in medical device activities.Monitor system performance, track compliance metrics, and report to the global MSS Leadership Team.Prepare for and support medical device audits/inspections; lead activities related to corrective and preventative actions for audit findings.Contribute to safety profile monitoring activities, including signal detection, evaluation, and prioritization.Review and provide input on product DFMEAs.Assist local staff with drafting and implementing Safety Data Exchange Agreements, if applicable.Collaborate with Regulatory Affairs and Quality Assurance to stay updated on safety reporting guidelines and incorporate them into practices.Assist in preparing, reviewing, and submitting aggregate safety reports.Prepare strategic documentation for medical device regulatory submissions (e.g., CEP, CER, PSUR, PMCF) and ensure timely completion.EDUCATION & COMPETENCIESMaster’s degree in a related health science or equivalent experience.RAC certification is a plus.5-7 years of experience in medical device regulatory submissions under EUMDR / MedDEV, with knowledge of standards like ISO, GSPR, and MDGC.Strong understanding of medical device regulatory requirements and compliance processes.Medical knowledge supporting safety activities; experience with nutrition/nutritional products is advantageous.Knowledge of global Vigilance reporting regulations.At least 3 years of leading complex projects or programs; global/regional experience preferred.Fluent in English, both spoken and written.Proficient in Windows, Word, Excel; experience with adverse event databases.Excellent communication and interpersonal skills.Strong organizational skills with the ability to prioritize multiple tasks.Commitment to compliance, scientific integrity, and quality.High accountability and reliability.Ability to work productively in a team and adapt to a fast-paced, changing environment.Resilience in high-stress situations and decision-making capabilities.Continuous improvement mindset and ability to positively influence team performance and culture.Broad knowledge of Abbott’s business and interdepartmental processes.Mastery of inventory deployment planning.Exceptional problem-solving skills.
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