Senior Manager, Regulatory Affairs (Hybrid)
Becton Dickinson NA

Job Info

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Job Description Summary
The Senior Manager of Regulatory Affairs will lead a group of high performing individuals focused on infusion pump new product development and sustaining projects.

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.

Summary of Job Responsibilities

The Senior Manager of Regulatory Affairs will provide regulatory support for infusion medical device products . 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.

Key Accountabilities

• 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.

Education

• Bachelor's degree in Science, Engineering, Business Administration or equivalent.
• Advanced degree (Master's degree or higher) preferred.

Experience

• Minimum 10 years of relevant work experience, preferably within the Medical Device industry.
• Experience working with external service providers, consultants, and regulators required.
• Prior experience in Regulatory Affairs with a focus on International Markets preferred.
• Knowledge of medical devices and their regulation strongly preferred.
• Familiarity with Infusion Pumps preferred.
• Ability to travel up to 10% domestically and internationally may be required.

Skills & Competencies

• 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.

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/careers

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.

Primary Work Location
USA CA - San Diego Bldg A&B

Additional Locations

Work Shift

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.

Salary Range Information
155 200,00 $ - 256 000,00 $ USD Annual

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