Senior Manager, Regulatory Affairs Dispensing

Overview

The Senior Manager of Regulatory Affairs will be based in San Diego, CA and will provide regulatory support for the Dispensing Platform. The role includes the development and implementation of regulatory strategies for new product submissions, handling existing product registrations including variations and renewals, interacting with global internal stakeholders as well as external consultants/service providers in support of registration activities, developing and maintaining documentation for compliance programs such as labeling, promotional material review, and other regulatory requirements.

This role will also oversee the hiring, training, and career development of their direct reports.

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. Join us to contribute to transformative solutions and to be supported to learn, grow and become your best self.

• Lead and mentor junior regulatory staff
• Lead existing registrations by preparing and filing variation and renewal applications for approvals or extensions of approvals in various countries around the world
• Provide oversight and guidance to external service providers supporting registration activities
• Work closely with cross-functional teams on submission strategy and documentation development for new product submissions
• Coordinate interactions between internal stakeholders and external service providers to ensure timely completion of registration milestones
• Assist in the maintenance of departmental systems used to track product registrations and compliance programs
• Directly contact regulators on behalf of the organization during inspections and/or meetings
• Perform additional tasks as required

• Strong project management skills and organizational abilities
• Excellent written and verbal communication skills
• Proficiency in Microsoft Office Suite, especially Excel and Power Point
• Proven ability to handle multiple priorities simultaneously while meeting deadlines
• Demonstrated interpersonal skills necessary to optimally collaborate across departments and geographies
• Proactive approach to problem solving with strong attention to detail
• Team player who takes initiative
• Ability to travel up to 10% domestically and internationally

• Bachelor's degree in Science, Engineering, Business Administration or equivalent
• Minimum 10 years of relevant work experience, preferably within the Medical Device industry
• Minimum 5 years of managing a regulatory team
• Experience working with external service providers, consultants, and regulators
• Prior experience in Regulatory Affairs
• Knowledge of medical devices and their regulation

• Advanced degree (Master's degree or higher)
• Familiarity with software controlled devices and Software as Medical Device (SaMD)

BD emphasizes on-site collaboration to foster teamwork and innovation. For most roles, a minimum of 4 days of in-office presence per week is expected to maintain our culture and operations. Remote or field-based positions will have different workplace arrangements as indicated in the job posting. Employment may be contingent upon proof of full COVID-19 vaccination where required, with accommodation requests considered per applicable law.

A career at BD means being part of a team that values your opinions and contributions, encourages you to bring your authentic self to work, and supports continuous learning and improvement. BD offers a culture that rewards accountability, collaboration, and growth. You will find opportunities to contribute to meaningful advances in health.

To learn more about BD, visit the careers site: https://

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, sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.

Primary

Work Location:

USA CA - San Diego TC Bldg C &

D. Additional Locations:
Work Shift.