We are the people who give possibilities purpose

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.

Job Description

At Becton, Dickinson and Company, we offer an outstanding opportunity for a Sr Mgr, Regulatory Affairs Ops in EMEA. This role provides the chance to work in a dynamic and ambitious environment where your contributions directly support our mission to improve global health outcomes. If you are driven by the desire to implement world-class regulatory strategies and successfully navigate complex legal frameworks, this position is for you!

Responsibilities

• Perform regulatory affairs tasks with high complexity under little to no direction, including requesting regulatory documents and entering specific RA information in the RA systems.
• Provide direction and mentorship to cross-functional team members on topics like clinical trials, promotional materials, and product launches. These launches occur in countries with regulatory frameworks of medium complexity.
• Review promotional materials to ensure they meet local regulatory requirements.
• Submit local clinical trials and report SAE (adverse events) to relevant authorities.
• Coordinate product launch activities and maintain the local notifications database.
• Analyze information on product recalls from the field corrective action team (APM global quality team) and provide comprehensive reports to government authorities.
• Establish and nurture connections with local regulatory authorities along with national and regional trade associations, serving as a primary contact person.
• Plan and complete registration activities, including labeling, with accountability for successful completion within agreed timelines to deliver licenses and ensure regulatory compliance and market access.
• Monitor and assess local regulatory trends and market intelligence information; provide advice and suggestions to the International RA team regarding potential significant risks and changes to implement.
• Contribute to the development of local regulatory affairs strategies.

Requirements

• Outstanding ability to provide mentorship and direction in a cross-functional team setting.
• Strong analytical abilities to interpret regulatory trends and market intelligence.
• Ability to develop and preserve seamless relationships with regulatory agencies and industry associations.
• Competence in planning and accomplishing registration activities with strict adherence to timelines.
• Excellent communication skills for reporting and advising on regulatory matters.
• Ambitious approach with a determination to successfully implement regulatory strategies.
• Extensive knowledge of local regulatory frameworks and adherence to compliance requirements.

Join us in making a difference and become part of a group that values collaboration, innovation, and excellence. Together, we can accomplish great things and positively influence global health outcomes!

Why Join Us?

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.

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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.

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