Job Description Summary
Reporting to Medication Management Systems (MMS) Pharmacy Automation (PA) team, the Staff Specialist of Regulatory Affairs provides regulatory expertise to MMS-PA platform. This individual facilitates the regulatory affairs activities within the MMS-PA platform. He/she contributes to the development of MMS-RA strategic and operational plans through sound assessments of regulatory pathways and risks, and sound regulatory programs. Such assessments may influence the scientific or technical direction of product design and/or development in support of worldwide registrations. The Staff Specialist of Regulatory Affairs will ensure functional excellence in regulatory activities to achieve timely worldwide clearance, approval, registration, and licensure of MMS-PA products with desired claims. This individual will help communicate new developments in worldwide regulations affecting MMS-PA products to MMS-PA stakeholders.
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We provide flexibility at the workplace! This position can be filled as full-time and part-time as well.
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!
Job Responsibilities:
- Provide pre-market regulatory expertise and facilitate regulatory affairs activities within MMS-PA.
- Develop and execute pre- and post-market regulatory strategies aligned with local, national, and international requirements.
- Prepare and manage regulatory submissions, including EU Technical Files for CE marking and global product registration materials.
- Act as a regulatory advisor in product development, ensuring compliance with standards, claims development, labeling, and promotional materials.
- Collaborate with Quality functions to address compliance activities and audit findings, supporting inspections by regulatory bodies.
- Monitor and communicate global regulatory developments, assess risks, and influence strategic and operational planning.
- Drive functional excellence by improving regulatory capabilities, fostering continuous improvement, and ensuring team engagement and efficiency.
Qualifications:
- Proven ability to perform advanced critical thinking, exercise independent judgment, and operate effectively within broad policies and practices.
- Track record of delivering innovative solutions to achieve business objectives, with strong business acumen and problem-solving skills.
- Exceptional communication (oral and written), negotiation, and interpersonal skills; adept at collaborating in cross-functional, regional, and matrixed team environments.
- Strong prioritization, organizational, and planning abilities with a detail-oriented approach, focused on accuracy, completeness, and timely results.
- Demonstrated ability to handle ambiguity, assess potential problems, and implement effective corrective actions to prevent recurrence.
- Experience as a change agent, driving continuous improvement initiatives and fostering adaptability in dynamic, fast-paced settings.
- Background in project management, continuous improvement, product development processes, and design control methodologies.
Education and Experience:
- B.A. or B.S. degree required with a focus in health science or life science field (biology, microbiology, chemistry, engineering, medical technology, etc.) preferred.
- MS degree in health science, regulatory affairs, or applicable discipline a plus.
- RAC/RCC Certification a plus.
- Minimum of 5 years directly applicable regulatory affairs work experience (e.g., IVD 510(k), PMA, de novo, IVDD and IVDR compliant tech files, etc.) required with experience in a medical device company preferred. Electrical equipment related experience/knowledge is preferred.
Click on apply if this sounds like you!
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
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Primary Work Location
DEU Kelberg - Rowastrasse
Additional Locations
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