Associate Regulatory Affairs Specialist (Laboratory Diagnostics) at Abbott

Zagreb, Grad Zagreb, Croatia

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Diagnostics, Medical DevicesIndustries

Requirements

Scientific background (Degree in Medicine, Biology, Chemistry or similar)
Strong interest to develop in Regulatory Affairs area
Prior experience in RA/QA function (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)

Responsibilities

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
Liaises with Manufacturing sites to generate and maintain new documentation as needed
Ensures DOA distribution requirements are met in assigned countries
Performs approval of Ad Promo material in own native language
Supports FSCA/FSN, MDI and PMS reporting to Authorities (applicable for non-EU assigned countries)
Performs/acts as backup for registration/notification process in the assigned countries
Follows implementation of regulatory compliance as required by international & local regulations and Abbott policies and procedures
Performs above mentioned activities for Abbott divisions specified in service agreements

Skills

Key technologies and capabilities for this role

Regulatory ComplianceProduct NotificationProduct RegistrationQuality SystemRegulatory AffairsDOA DistributionAd Promo Approval

Questions & Answers

Common questions about this position

What compensation and benefits does Abbott offer?

Abbott provides competitive salaries, bonus potential, and an excellent package of benefits.

Is this a remote position or office-based?

This is an office-based position requiring daily presence in the Zagreb office, with a minimum of 4 days per week office work.

What qualifications and skills are required for this role?

A scientific background with a degree in Medicine, Biology, Chemistry or similar is required, along with fluency in Croatian and English, ability to work independently with attention to detail, and knowledge of PC- and internet-based applications. Prior experience in RA/QA is an asset, and a strong interest in developing in Regulatory Affairs is a must.

What is the work environment like at Abbott?

Abbott is recognized as a great place to work, one of the most admired companies by Fortune, and best for diversity, working mothers, female executives, and scientists, offering career development and a supportive environment.

What makes a strong candidate for this Associate Regulatory Affairs Specialist role?

Strong candidates will have a scientific degree, fluency in Croatian and English, a strong interest in Regulatory Affairs, and the ability to work independently with attention to detail in the Zagreb office.

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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