BD

Manager, Regulatory Affairs

BD  •  Columbus, NE (Onsite)  •  1 day ago
Apply
AI can make mistakes so check important info. Chat history is never stored.

Job Description





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

The Regulatory Affairs Manager is responsible for leading and coordinating regulatory activities to ensure compliance with applicable regulations, support product registrations and market access, facilitate product launches, and maintain effective relationships with regulatory authorities. This role provides regulatory guidance to cross-functional teams, monitors regulatory changes and industry trends, manages regulatory documentation and submissions, and contributes to the development and execution of regulatory strategies that support business objectives and ensure ongoing compliance.

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 to cross-functional team members on topics like promotional materials, regulatory compliance, and product launches.
  • 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 required documentation to government authorities.
  • Establish and nurture connections with local and regional regulatory authorities, 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 BU RA team regarding potential significant risks and changes to implement.
  • Contribute to the development of local regulatory affairs strategies.

Requirements

  • Ability to provide 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.

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.

Required Skills

Optional Skills

Primary Work Location

MEX Mexico City - Lomas de Chapultepec

Additional Locations

Work Shift

BD

About BD

BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its more than 70,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com.

See community guidelines here: https://tinyurl.com/yunjmzkx.

Industry
Manufacturing & Production
Company Size
10,000+ employees
Headquarters
Franklin Lakes, New Jersey
Year Founded
Unknown
Website
bd.com
Social Media