Zagreb, HRV
10 days ago
Associate Regulatory Affairs Specialist (Laboratory Diagnostics)
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. **Working at Abbott** At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to: + Career development with an international company where you can grow the career you dream of. + Competitive salaries, bonus potential and excellent package of benefits. + A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. + A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. **The Opportunity** For our **Core Diagnostics Division CDx** we are looking for an **Associate Regulatory Affairs Specialist** to join our team in Croatia. This is an office-based position requiring daily presence in our Zagreb office. Regulatory Affairs Specialist executes tasks required for regulatory compliance in areas of product notification/registration, responding to customer and tender requests, promotional and approval in own native language and DOA distribution. **What You'll do:** + Ensures that all activities are performed in compliance with quality system requirements. + Acts as a primary contact for country regulatory Authorities within product notification/registration process. + Performs product notifications/registrations in assigned countries, following country-specific requirements, processes and timelines. + Responds to customer and tender requests. + Liaising with Manufacturing sites to generate and maintain new documentation as needed. + Ensures DOA distribution requirements are met in assigned countries. + Performs approval Ad Promo material in own native language. + Supporting FSCA/FSN, MDI and PMS reporting to Authorities (applicable for non-EU assigned countries). + Perform /act as backup for registration / notification process in the assigned countries. + Responsible for following of the implementation of regulatory compliance as required by international & local regulations and Abbott policies and procedures. + Perform above mentioned activities for Abbott divisions specified in service agreements. **Required qualifications & background:** + Scientific background (Degree in Medicine, Biology, Chemistry or Similar). + Strong interest to develop in Regulatory Affairs area is a must. + Prior experience in RA/QA function would be an asset. + Fluent in Croatian and English (written and spoken). + Ability to work independently, with attention to detail. + Knowledge of PC- and internet-based applications. + Ability to work from Zagreb office (minimum 4 days per week office work). Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal. 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
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