Associate Regulatory Affairs Specialist (Laboratory Diagnostics) at Abbott Pediatrics

City of Zagreb, , Croatia -

Full Time

Start Date

Immediate

Expiry Date

27 Feb, 26

Salary

0.0

Posted On

29 Nov, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Compliance, Product Notification, Registration Process, Customer Requests, Documentation, Attention to Detail, Fluent in Croatian, Fluent in English

Industry

Hospitals and Health Care

Description

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.

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Responsibilities

The Associate Regulatory Affairs Specialist ensures compliance with quality system requirements and acts as the primary contact for regulatory authorities. They perform product notifications and registrations, respond to customer requests, and liaise with manufacturing sites for documentation.