Job Description Summary
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.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us.
Position Summary
The Senior Manager of Regulatory Affairs reports directly to the Senior Director of Regulatory Affairs. This position is responsible for supporting MMS Pharmacy Automation products and associated Software and Accessories on a global basis from a Regulatory Affairs standpoint. Support will consist of new product development, sustaining, and end of life activities. The Senior Manager will also oversee the hiring, training, and career development of their direct reports.
Key responsibilities:
- Support the monitoring and interpreting of current and new regulatory requirements and international standards for U.S. and RoW
- Lead regulatory effort to comply with new and existing regulations (e.g., Electrical and Electromagnetic Equipment, Machinery, Data and Cybersecurity, Board of Pharmacy, Environmental)
- Lead and develop direct report associates to ensure regulatory compliance
- Problem solve and escalate regulatory and compliance issues to senior management as necessary
- Provide effective leadership and team development, effective communication, and quick responses to customers
- Drive continuous improvement in internal processes and customer satisfaction
- Identify, develop, and mentor high performing regulatory talent
- Develop and implement global regulatory strategy for MMS Pharmacy Automation products and software
- Support the monitoring, interpreting, and implementing of current and new regulatory requirements and international standards for U.S., EU., and RoW
- Assure that QMS requirements are followed and executed consistently from RA perspective
- Oversee efforts for Technical File creation and remediation, collaborating with cross-functional teams for required content
- Support regulatory impact assessments for change controls and other RA/QA items from a review and approve level
- Assists in preparing, auditing, editing, and publishing registration documentation, as needed
- Support business export control (BEC) listing of product for release globally per RA requirements
- Performs other duties and assignments as required
Minimum Requirements: - Experience: Minimum of 8 years of directly related Regulatory Affairs experience in medical devices and/or in vitro diagnostic and/or regulated product field
- Education: Bachelor's degree in biology, engineering, or other science-related discipline
- Technical Skills:
- Experience with Regulatory and Quality Information Management systems (SAP, RIM, or related systems)
- Digital literacy with MS Word, Excel, PowerPoint, Teams
- Project Management experience
Preferred Qualifications: - Education: Advanced degree (e.g., MS, PhD)
- Certification: RAPS RAC certification
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.
For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.
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.
To learn more about BD visit
https://bd.com/careersBecton, 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.
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Primary Work LocationUSA NC - Durham - Roche Drive
Additional LocationsWork Shift