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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 an individual contributor, with guidance from manager/team, functions to support Medical Safety & Surveillance (MSS) by reviewing, assessing, and summarizing medical device complaint information for complex investigations and risk assessments. Critically assess aggregate safety data from medical devices and communicates findings to internal stakeholders. Independently creates and delivers device medical safety training to a Global audience. Drafts documentation, including data reviews, clinical evaluations, literature reviews and standard operating procedures.
Major Responsibilities
* Create and present medical safety related analyses, reports, and/or assessments orally and/or in writing within/ outside the Medical Safety and Surveillance department
* Gather, critically analyze, and present findings from Medical Safety and Surveillance complaint data on a periodic basis, including tracking and trending activities
* Ensure adherence to departmental standard operating procedures (SOPs), and draft new SOPs as needed
* Develop Medical Safety and Surveillance training materials and present to a broad international audience
* Assist in preparing literature or website searches and data analysis for regulatory documentation supporting medical device registration
* Conduct periodic literature searches, summarize findings and present information to a cross-functional team
* Provide backup support to colleagues on day-to-day medical device complaints processing and conduct medical follow-up calls to customers to obtain adverse event and/or complaint details
* Determine complaint reportability to the competent authority; drive timely vigilance reporting within regulatory time-frames
* Other duties/projects/support as assigned
Education & Competencies
* Bachelor of Science, health science background is a plus (e.g., dietitian, pharmacist, nurse)
* RAC certification a plus
* 2-3 years Medical Device experience (aggregate data review, risk assessment, DFMEA, patient safety)
* Data analytics / strong Excel, Power BI and/or data visualization skills
* Medical knowledge to apply critical thinking and data analysis to Medical Safety data and/or Medical Device risk assessments
* Basic understanding of Global Medical Device regulations (primarily EU MDR, MedDEV), clinical research, and international guidelines/standards related to medical devices (ISO, GSPR, MDGC)
* Willingness to learn other applicable Medical Device regulations, standards and guidelines
* Ability to adhere to standard operating procedures (SOPs)
* Strong ability to present medical and scientific training/data orally and in writing
* Computer proficiency (Windows, Word, Excel)
* Enjoys working in a collaborative, multidisciplinary, global team
* Works independently
Connect with us at www.abbott.com, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Management and Manufacturing
Industries
* Hospitals and Health Care
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