JOB 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.

About the Role

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; to be based in Warsaw, Poland.

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.

Senior Specialist will act as a strategic interface between Regulatory Affairs and Commercial/Marketing teams, legal manufacturers and the cross functional team supporting product launches, promotional compliance, and lifecycle management.

Key Responsibilities

• Act as a regional regulatory expert for EE/EEA/CEE and Turkey

• Provide strong IVDR expertise, including regulatory intelligence and lifecycle/change management

• Serve as a strategic regulatory partner to global team, Commercial and Marketing, including promotional material review, claim alignment, and launch readiness

• Ensure product registrations and market access activities while ensuring governance, compliance, and audit readiness

Regulatory Oversight of Commercial Activities:

• Submissions, Commercialization & Market Access: Support product registrations and notifications; ensure launch readiness; provide regulatory documentation for tenders, distributors, and customers.

• Lifecycle & Change Management: Communicate regulatory changes; assess commercial impact of variations, discontinuations, and supply changes; support UDI and EUDAMED implementation.

• Review and approve promotional and commercial materials: ensure labels, claims, and messaging align with CE‑marked indications and approved technical documentation.

• Regulatory–Commercial Interface: Act as primary regulatory partner to Sales, Marketing, global regulatory and Commercial teams; provide training and regulatory guidance.

• Governance, Compliance & Quality: Ensure compliance with EU regulations , other applicable regulations in the region and internal procedures; support audits, PMS, vigilance, and QMS maintenance.

• Regulatory Intelligence: Monitor evolving IVD regulations; assess portfolio impact; maintain strong relationships with authorities and industry associations.

Required qualifications & background:

• Education: Bachelor’s degree or equivalent in medical, biomedical, pharmaceutical, or other science‑related field. ISO 13485 training is an advantage.

• Experience: Minimum 7 years of Regulatory Affairs experience in IVD or medical devices with deep IVDR/MDR expertise.

• Strong understanding of EU regulations governing registration, promotional materials, vigilance, and customer‑facing communications.

• Proven ability to lead complex cross‑functional projects and support commercial objectives.

• Languages: Fluent English required; German, Polish, French, Spanish, or other European languages are a strong asset.

• Skills: Excellent organizational, analytical, communication, and stakeholder‑influencing skills; proficiency in Microsoft Office tools.

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 @Abbott News and @Abbott Global.

The base pay for this position is

N/A
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Regulatory Operations

DIVISION:

ID Infectious Disease:

LOCATION:

Poland > Park Postepu : Building B

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Not Applicable