Faites partie de quelque chose de plus grand chez BD. Ici, vous nous aiderez à maintenir nos normes élevées d'un point de vue réglementaire à tous les niveaux, avec un accent particulier sur les soumissions. Cela exige une attention aiguë aux détails, d'excellentes compétences en communication et une passion pour continuer à apprendre et à mettre à jour vos connaissances, ce que nous vous aiderons à faire avec des opportunités d'apprentissage régulières. Ici, vous utiliserez vos connaissances approfondies des réglementations et des exigences de la FDA, du Canada et de l'ISO/MDD entourant les dispositifs médicaux pour atteindre finalement un objectif unique : faire progresser le monde de la santé™. Chez BD, vous pouvez faire une véritable différence d'une personne.
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Job Type:
Full-Time -
Job Level:
Entry to Senior -
Travel:
Varies -
Salary:
Competitive -
Responsibilities
Job Description Summary
The Regulatory Affairs Specialist will provide regulatory support for various products from BD portfolio. This role involves ensuring compliance with applicable regulations for medical devices and in vitro diagnostics in CEE countries.The Regulatory Affairs Specialist is responsible for creating, submitting, and maintaining product notifications in CEE countries, tracking regulations, updating relevant systems and trackers, and supporting the Regulatory Affairs team as needed.
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!
Main responsibilities will include:
- Create, submit, and maintain product notifications.
- Review and approve documents to ensure accuracy, completeness, and compliance with regulations.
- Maintain metrics related to product releases, ensuring timely compliance with regulatory requirements.
- Track regulations applicable to medical devices and in vitro diagnostics, monitoring both EU and local requirements.
- Review advertising and promotional materials to ensure compliance with local and corporate requirements.
- Support marketing, sales, and tenders by providing technical support and addressing regulatory questions.
- Input and maintain accurate data, including licenses and registration records, in internal regulatory databases.
- Report product complaints according to corporate and regional requirements.
About You
- Hold a Bachelor's Degree in relevant fields such as Life Sciences, Pharmacy, Biomedical Engineering, or a related discipline.
- Have a minimum of 1-2 years of experience in Regulatory Affairs, preferably within the medical device or in vitro diagnostics industry.
- Possess exceptional verbal and written communication skills for effective interaction with competent authorities, trade associations, and internal teams.
- Demonstrate the ability to work effectively with diverse teams.
- Exhibit strong analytical skills to track, interpret, and apply regulatory changes and their impact on product compliance.
- Show high accuracy and thoroughness in reviewing and approving documents, ensuring compliance with regulations.
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
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
Required Skills
Optional Skills
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Primary Work Location
POL Warsaw - ul. OsmanskaAdditional Locations
ESP San Agustin del Guadalix, HRV CroatiaWork Shift
Success Profile
What makes a successful Regulatory Affairs Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.
- Analytical
- Collaborative
- Communicator
- Persuasive
- Problem-solver
- Skilled presenter
Advancing the world of health™
BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.