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.
The Senior Regulatory Affairs Specialist is responsible for executing and maintaining EO Hub compliance activities for importers, distributors, and Authorised Representatives in accordance with applicable legislations.
The role acts as a subject matter expert for the execution of processes related to device registrations, compliance verification activities, and the operational implementation of associated processes. The individual works with cross-functional stakeholders to ensure activities are completed accurately, consistently, and in accordance with applicable procedures and quality system requirements.
Main responsabilities will include
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Create, maintain, and update Authorised Representative mandates in accordance with applicable regulatory requirements and internal procedures.
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Perform and support device registration and verification activities, ensuring required information is complete, accurate, and aligned with applicable regulatory and quality system requirements. Support lifecycle updates of the records/registrations.
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Request, track, and maintain Certificates of Free Sale (CFS).
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Perform and support verifications required to comply with legislations within the EO Hub scope.
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Document verification outcomes, follow up on identified gaps, and maintain applicable databases, trackers, and systems/tools to ensure accurate tracking of activities.
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Contribute to the implementation and maintenance of effective controls to ensure ongoing compliance with applicable procedures, standards, and regulatory requirements.
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Manage and/or contribute to continuous improvement projects, including process optimisation, simplification, standardisation, and effectiveness improvements.
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Develop, maintain, and continuously improve associated job aids, work instructions, templates, trackers, and other quality system documentation.
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Support internal and external audits, inspections, and regulatory assessments by providing documentation, expertise, and regulatory rationale as required.
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Analyse and report compliance metrics, trends, and key performance indicators to support management oversight and continuous improvement initiatives.
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Identify regulatory/quality compliance risks and proactively recommend mitigation strategies.
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Provide training and regulatory awareness sessions to internal stakeholders as required.
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Follow all applicable company policies, procedures, and quality system requirements.
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Perform other duties as assigned in support of the QRA EMEA organisation.
Requirements
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Educated to a minimum of bachelor's degree level, preferably in a scientific field
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Minimum of 3 years relevant experience with European Union medical devices and in vitro diagnostic medical devices regulations.
- Advanced level of English is required.
Salary range for this role: EUR 42,000 - EUR 50,000
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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ESP Barcelona
ESP San Agustin del Guadalix
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
€41,900.00 - €67,025.00 EUR Annual
