Senior Manager, Regulatory Affairs Dispensing

Becton Dickinson Medical Devices • San Diego, CA

21d • Onsite

About The Position

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 but is not limited to 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, 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.

Requirements

• Strong project management skills and organizational abilities
• Excellent written and verbal communication skills
• Proficiency in Microsoft Office Suite, especially Excel and PowerPoint
• 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

Nice To Haves

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

Responsibilities

• 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.

Benefits

• At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You .
• Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility.
• There are many factors, such as location, that contribute to the range displayed.
• The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position.
• Salary or hourly pay ranges may vary for Field-based and Remote roles.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior