Be part of something bigger at BD. Here, you’ll help us maintain our high standards from a regulatory perspective at all levels, with a keen focus on submissions. It requires acute attention to detail, excellent communication skills and a passion to keep learning and updating your knowledge, which we’ll help you do with regular learning opportunities. Here, you’ll use your in-depth knowledge of FDA, Canadian and ISO/MDD regulations and requirements surrounding medical devices to ultimately achieve a singular goal: advancing the world of health™. At BD, you can make a true difference of one.
Responsibilities
Job Description Summary
The Vigilance Administrator will be responsible for supporting administrative activities associated with EMEA Vigilance Centre of Excellence ensuring compliance with internal and external requirements while fostering a culture of quality, innovation, and operational excellence.Job Description
About the role
- Reportingtothe EMEA Vigilance Manager – EMEA,the Vigilance Administrator will be responsible for supporting administrative activities associated with EMEA Vigilance Centre of Excellence ensuring compliance with internal and external requirements while fostering a culture of quality, innovation, and operational excellence.
Key responsibilities:
- Monitoring and managing dedicated vigilance shared mailboxes for the team
- Collaborating with the Vigilance Specialists to submit Adverse Event reports to Regulatory Agencies and Notified Bodies, where applicable.
- Maintaining accurate records of vigilance-related activities within the TrackWise system, and the local tracker.
- Supporting the generation of metrics for Vigilance Leaders and Senior Management.
- Identifying and assessing vigilance-related risks and support the development of mitigation strategies.
- Supporting with non-reportable Decision Tree approval for SMAX related complaints
- Ensuring compliance with vigilance policies and procedures.
- Supporting and participating in audits performed by internal and external bodies.
- Assisting in identifying and implementing opportunities for process enhancements/optimization, including technology to enable PMQ organizational agility in relation to evolving business requirements, customer needs/experience and regulatory requirements.
- Undertaking any other duties as requested by EMEA Post Market Quality leadership to support the EMEA and Global Quality organisation.
Specific Skills Required:
- Strong attention to detail with strong organisational skills
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
- Ability to lead multiple tasks and prioritize effectively with a pro-active attitude.
- Strong problem-solving skills, written and verbal communication and interpersonal skills.
- Ability to work independently and as part of a team.
- Fluent English (oral and written)
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!
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 Wroclaw - LegnickaAdditional Locations
Work 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