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Senior Regulatory Affairs Specialist – CEEI

In-Office, Multiple Locations

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ID da oferta
R-553449
Category
Regulatory Affairs
Location
Multiple Locations

We are the people who give possibilities purpose

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.

Job Description

About the Role

  • The Senior Regulatory Affairs Specialist provides dedicated regulatory support for the transition of BDB and DS registrations and licenses from BD to Waters across the CEEI region as part of the Nebula Program. The role ensures regulatory compliance, business continuity, and timely execution of regulatory activities associated with the transition. 
  • This is a fixed-term contract (until February 2028) role supporting a major regulatory transition project across the Central and Eastern Europe region.

Key Responsibilities:

  • Manage regulatory submissions, notifications, amendments, and registrations across CEE countries.
  • Ensure compliance with EU and local regulatory requirements during product transitions.
  • Collaborate with cross-functional teams including Quality, Supply Chain, Legal, Commercial, and external stakeholders.
  • Assess regulatory risks and drive mitigation plans to support uninterrupted market access.
  • Maintain regulatory documentation, databases, trackers, and status reports.
  • Act as a regulatory point of contact for authorities, partners, and internal teams.
  • Provide regulatory support for customer, tender, and commercial activities

What We're Looking For:

  • Bachelor's degree in Life Sciences, Pharmacy, Chemistry, Biology, Biomedical Engineering, or a related field.
  • 3+ years of Regulatory Affairs experience, ideally within medical devices or IVD.
  • Strong knowledge of EU Medical Device Regulations and regulatory requirements across CEE markets.
  • Experience working with regulatory submissions and cross-country regulatory activities.
  • Fluent English and excellent stakeholder management skills.
  • Strong analytical, organizational, and problem-solving abilities.
  • Preferred
  • Experience with regulatory systems such as Veeva Vault or RIM.
  • Regulatory Affairs certification (RAC) or advanced scientific degree.
  • Experience interacting with regulatory authorities and external regulatory partners.

Why Join Us?

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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

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

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.

Required Skills

Optional Skills

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Primary Work Location

CZE Praha - Na hrebenech

Additional Locations

HRV Croatia

Work Shift

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information

Kč766,700.00 - Kč1,169,225.00 CZK Annual
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