Regulatory Affairs Specialist - Hybrid Prague, Praha

Regulatory Affairs Specialist - Hybrid

**Job Description Summary**: 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!
**This is a fixed-term contract (1.2 year) with potential possibility to extend the contract.**
**Main responsibilities will include**:
- Creating, submitting, and maintaining product notifications in Czech Republic and Slovakia
- Reviewing and approving documents required for product notifications
- Maintaining up to date metrics with product releases completed
- Tracking regulations applicable for medical devices and medical devices for in vitro diagnostic in Czech Republic and Slovakia
- Reviewing and approving advertising / promotional materials for BD products in Veeva Vault to ensure compliance with local and corporate requirements; maintaining up to date metrics
- 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)
- Supporting the EMEA Regulatory Affairs team, if required
- Ensuring that Competent Authority communications regarding regulatory issues are responded to in a timely manner
- Taking care for reimbursement activities and reimbursement-related local regulations
**Duties / Accountibilities**:
- Successful execution of strategic alignment process in Czech Republic and Slovakia for BD products
- Successful approval and maintenance of product notifications / notifications of change
- Promotional materials review and approval
- Keeping up to date RA databases per corporate, regional and local requirements
**About you**
- Degree, preferably in a scientific discipline
- 1-3 years RA experience in medical devices / medical devices for in vitro diagnostic or pharmaceuticals or life science
- related
- Advanced English, ideally good command of Czech language
- 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
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.
**Primary Work Location**: CZE Praha - Na hrebenech
**Additional Locations**:
**Work Shift**:

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