Associate Regulatory Affairs Specialist (Laboratory Diagnostics)
Abbott
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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