Job Description Summary

The RA Senior Specialist CEE is responsible for the creation, maintenance and utilization of systems and processes to ensure that BD fulfills the regulatory responsibilities and activities of CEE countries to support the business. This will involve working with internal and external people and stakeholders from multiple segments, functions, and countries to ensure that BD is compliant in an efficient and effective manner to progress the business. The role also supports the wider EMEA Regulatory Affairs team as required.

Job Description

We are the makers of possible

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Why join us?

A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.

Become a maker of possible with us!

Main responsibilities will include:

• Ensure regulatory compliance of all products placed on the market in CEE countries.
• Lead regulatory submissions, including preparation of dossiers for product registrations and notifications.
• Act as a subject matter expert for regulatory requirements in CEE countries and Ukraine.
• Maintain regulatory databases and systems for key regulatory data.
• Execute regulatory strategies in accordance with agreed timescales.
• Review and approve advertising, promotional materials, and product labelling for compliance.
• Assess changes to registered products for their impact on product registration and take necessary actions.
• Conduct regulatory intelligence and advocacy activities, tracking and reporting health authority trends.

About You

• Hold a Bachelor's Degree in Life Sciences, Pharmacy, Biomedical Engineering, or a related discipline.
• Have a minimum of 3 years of experience in Regulatory Affairs, preferably within the medical device or in vitro diagnostics industry.
• Possess good knowledge of EU and local regulations applicable to products in CEE markets.
• Demonstrate the ability to work well individually with minimal oversight and as part of a dynamic team.
• Exhibit strong analytical skills to provide solutions, draw conclusions, and communicate them effectively.
• Show excellent organizational skills and attention to detail.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

To learn more about BD visit:  https://bd.com/careers

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Primary Work Location

POL Warsaw - ul. Osmanska

Additional Locations

Work Shift