Abbott Rapid Diagnostics (ARDx) is seeking a Senior Specialist, Regulatory Affairs to serve as a regional regulatory expert supporting Eastern Europe, EEA, CEE, broader Europe, and Turkey
Job Summary
Abbott Rapid Diagnostics (ARDx) is seeking a Senior Specialist, Regulatory Affairs to serve as a regional regulatory expert supporting Eastern Europe, EEA, CEE, broader Europe, and Turkey.
This role is a senior individual contributor position with significant responsibility for enabling commercialization, supporting go‑to‑market strategies, and ensuring compliance with IVDR and applicable local regulations.
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.
Matching Summary
Abbott Rapid Diagnostics (ARDx) is seeking a Senior Specialist, Regulatory Affairs to serve as a regional regulatory expert supporting Eastern Europe, EEA, CEE, broader Europe, and Turkey.
Skills & Requirements
Must-have
IVDR expertise
regulatory intelligence
lifecycle management
promotional material review
launch readiness
product registrations
market access
Nice-to-have
stakeholder influencing skills
cross-functional project leadership
ISO 13485 training
Key Requirements
Bachelor’s degree or equivalent in science-related field
Minimum 7 years of Regulatory Affairs experience in IVD or medical devices