BD (Becton, Dickinson and Company) Jobs

Job Information

BD (Becton, Dickinson and Company) Regulatory Affairs Specialist (fixed-term) in Warsaw, Poland

Job Description Summary

This is a hybrid position.

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!

About the Role

This is a fixed-term contract (12 months) with the possibility to extend the contract.

Main responsibilities will include:

  • Creating, submitting, and maintaining product notifications in CEE countries to support the BDX business (MDS and Life Sciences)

  • Reviewing and approving documents required for product notifications

  • Maintaining monthly metrics with product releases completed for the month

  • Tracking regulations applicable for medical devices and medical devices for in vitro diagnostic in the CEE countries (European and local regulations)

  • Reviewing and approving advertising / promotional materials for MDS and Life Sciences in Veeva Vault to ensure compliance with local and corporate requirements

  • Maintaining trackers with reviewed and approved promo materials

  • Providing requested documents to the customers

  • Providing support to marketing and tenders in responding to technical questions

  • Collaboration with regional RA teams, using internal systems as applicable, to obtain strategic alignment for product launches and releases as required and circulating approved strategic alignment to commercial team

  • Inputting and maintaining data, including licenses and registration records in internal regulatory database(s) as required (RIM, DMS)

  • Supporting the EMEA Regulatory Affairs team, if required

  • Ensuring that Competent Authority communications regarding regulatory issues are responded to in a timely manner

About you

  • Degree, preferably in a scientific discipline

  • 1-3 years RA experience in medical devices / medical devices for in vitro diagnostic or pharmaceuticals

  • Fluent English

  • Self-motivated, comfortable with working with people remotely, thus good communication skills, both oral and written, are needed

  • Organized, analytical thinker with attention to details

Primary Work Location

POL Warsaw - ul. Osmanska

Additional Locations

Work Shift

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.