Czech Republic Job Openings

BD

Regulatory Affairs Specialist

Prague

August 20, 2024

Job Description Summary
The role involves creating, submitting, and maintaining product notifications for various BD portfolios in Czech Republic and Slovakia.
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 Med Tech 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!

This is a fixed-term contract (end of February 2026).

Scope of Responsibilities:
  • Product Notifications: Create, submit, and maintain product notifications to support business operations.
  • Document Review: Review and approve documents required for product notifications.
  • Metrics Maintenance: Maintain monthly metrics related to product releases.
  • Regulatory Tracking: Track EU and local regulations for medical devices and in vitro diagnostic devices in the region. Support Regulatory Intelligence team.
  • Promotional Material Review: Review and approve advertising and promotional materials to ensure compliance with local and corporate requirements. Maintain trackers for reviewed and approved promotional materials.
  • Documentation: Provide requested documents to customers and internal teams.
  • Support Functions: Provide support to BD internal teams by responding to technical questions.
  • Collaboration: Collaborate with regional RA teams to obtain strategic alignment for product launches and releases.
  • Data Management: Input and maintain data, including licenses and registration records, in internal regulatory databases.
  • Team Support: Support the EMEA Regulatory Affairs team, if needed.
  • Regulatory Communication: Ensure timely responses to communications from Competent Authorities regarding regulatory issues.
  • Reimbursement Activities: Manage reimbursement activities and ensure compliance with local regulations.

About you
  • Degree, preferably in a scientific discipline
  • Preferably 1-3 years RA experience in medical devices / medical devices for in vitro diagnostic or pharmaceuticals or life science- related
  • Advanced English and Czech language
  • Self-motivated, comfortable with working with people remotely, thus good communication skills, both oral and written, are needed
  • Highly organized with strong analytical thinking and attention to detail

Click on apply if this sounds like you!

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

Primary Work Location
CZE Praha - Na hrebenech
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