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.

The Opportunity:

For our Rapid Diagnostics Division we are looking for an experienced professional to join our international, regulatory team as a Regulatory Affairs Coordinator. This will be a full-time, office-based role working out from our Warsaw (Mokotow) location.

The successful candidate will start on a 12-months, fixed-term contract with an external agency (umowa o pracę na czas określony).

What You'll do:

This is a role with two components where you will be responsible for the project management of IVDR transition in the EMEA region as well as all regulatory related activities related to product registration and life cycle management of the Rapid Diagnostic Portfolio in the Western Europe region.

IVDR implementation:

• Work closely with Global Project Manager and country Regulatory teams to gather status updates for EMEA
• Set up and lead a monthly EMEA IVDR cross functional meeting to share progress of the IVDR project in the region 
• Track metrics in monthly Regulatory Review meeting

Western Europe:

• Be the primary point of contact for Abbott Affiliates and distributors in the region for Regulatory related activities 
• Work closely with the manufacturing sites to gather the necessary documents needed for local notification when required.
• Track Regulatory submissions and approvals in Abbott database in a timely manner and with high quality data accuracy 
• Maintain regulatory and language requirements for the region  
• Monitor applications under regulatory review. Communicate application progress to internal stakeholders. 
• Provide regulatory input to product lifecycle planning and strategies.
• Ensure compliance with product post marketing approval requirements 
• Review and approve advertising and promotional items to ensure regulatory compliance. Ensure external communications meet regulations.
• Monitor impact of changing regulations and update internal stakeholders. 
• Represent Abbott in industry association meeting 
• Represent Regulatory in cross functional meetings 
• Other duties as assigned, according to the changing needs of the business.

Required qualifications and background:

• Minimum of a Bachelor’s Degree (BA/BS) from an accredited University.
• Minimum of 5 years of experience in a Biotech / Pharma / Medical Device/ IVD/ Regulated Industry.
• Experience in project management.
• Experience in data management and Power BI would be a plus.
• Proficient in English. French, Spanish or Italian would be a plus.
• Demonstrated success in the Pharma or Medical Device Industry.
• Good knowledge of EU regulations.
• Excellent communication and relationship management skills.
• Ability to adapt quickly and effectively to shifting priorities.
• Very strong attention to detail.
• Strong sense of ownership.
• Adaptability, Innovation, Initiative, Teamwork, Quality of Work, Commitment.
• Strong skills in Microsoft Office, especially in Word, Excel, and PowerPoint.

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. 

     

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:

Yes, 5 % of the Time

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable