Senior Regulatory Affairs Specialist – CEEI

Pracovní nabídka

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.

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

Profile:

• 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.
• Advanced English
• Strong analytical, organizational, and problem-solving abilities.

Offer:

• Edenred card
• Life insurance
• Contribution to a private pension plan
• Additional 3 days of paid sick leave per year
• Participation in the Global Share Investment Plan (GSIP)
• Comprehensive onboarding and continuous learning opportunities