Job Description Summary

The Regulatory Affairs Specialist, EMEA Regulatory Affairs Operations is responsible to execute and support the activities of the Regulatory Affairs Operations team. The scope extends across BDx and all EMEA countries. The activities are related with regulatory responsibilities to execute regulatory processes, provide support and/or lead (with moderate oversight) projects and activities to create, implement and maintain harmonized and efficient processes, systems & tools, and metrics to achieve the EMEA regulatory objectives effectively. The role will also support the wider EMEA regulatory affairs team as required.

Job Description

Main responsabilities will include:

·Prepare, implement and maintain the harmonized regulatory documents within BD quality management system (as procedures, work instructions, training matrix, change controls, CAPAs, and others) to ensure compliance with regulatory and corporate requirements.

·Create/implement, update, and maintain working tools and databases to support EMEA BDX RA processes and activities execution and facilitate collaboration within EMEA RA organization and with key stakeholders.

·Report to regional management on the performances of the regulatory processes through data, including any needs for improvement.

·Support and/or lead EMEA BDX RA teams and their stakeholders with data management (metrics & dashboards), processes/activities, and RA systems & tools automation and improvement ad-hoc requests and projects (implement and maintain excellence program management to execute projects or quick continuous improvement actions that will drive harmonization and efficiency within EMEA RA organization).

·Create/implement, update, and maintain metrics and dashboards related and relevant to EMEA RA organization and stakeholders.

·Lead RA assessments for select projects, liaising with global divisions, country and regional stakeholders as needed.

·Understand and follow local, regional, and corporate procedures applicable to role.

·Provide input into key business decisions and resource planning as required.

·After identifying possible business or processes risks, recommend mitigations or contingency planning to management decision make.

·Understand key business driver and team goals and align individual goals accordingly.

·Understand BD culture and values and reflect them in his/ her own behavior.

·Support the wider EMEA regulatory affairs team as required.

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

Click on apply if this sounds like you!

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 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.

To learn more about BD visit: https://bd.com/careers

Required Skills

Optional Skills

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Primary Work Location

ESP San Agustin del Guadalix

Additional Locations

Work Shift