Job Description

Job Description Summary 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 its no small feat. It takes the imagination and passion of all of usfrom design and engineering to the manufacturing and marketing of our billions of MedTech products per yearto 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 youll be supported to learn, grow and become your best self. Become a maker of possible with us.

The Associate Director of Regulatory Affairs will provide regulatory support for medical device systems within infusion technologies. The role includes but is not limited to the development and implementation of regulatory strategies for new product submissions, project management for regulatory affairs 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.

Responsibilities

• Lead regulatory submission activities for various initiatives
• 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 submission milestones
• Assist in the maintenance of departmental systems used to track projects and ongoing operational activities
• Directly interface with regulators as needed

Education and Experience required

• Bachelors degree in science STEM engineering
• Minimum of 10 years of relevant experience in the medical device industry within Quality and/or R&D, including at least 5 years in Regulatory Affairs. Must have handson experience with complex medical device systems and software, specifically ClassII or higher devices.
• Experience working with external service providers, consultants, and regulators.
• Minimum of 12 years of proven experience in people management, including team leadership and performance oversight.

Knowledge and Skills required

• Demonstrated interpersonal skills necessary to optimally collaborate across departments and geographies required

Preferred qualifications

• Advanced degree, masters degree or higher preferred with a focus in a scientific discipline
• Familiarity with Infusion Pump Systems
• Regulatory Affairs Certification (RAC) preferred
• Project Management Certification preferred

Work environment

• Travel up to 20% domestically and internationally may be required

At BD, we prioritize onsite collaboration because we believe it fosters creativity, innovation, and effective problemsolving, which are essential in the fastpaced healthcare industry. For most roles, we require a minimum of 4 days of inoffice presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and worklife balance. Remote or fieldbased positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Companys receipt of sufficient proof that you are fully vaccinated against COVID19. In some locations, testing for COVID19 may be available and/or required. Consistent with BDs 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. Its also a place where we help each other be great, we do whats 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, youll 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

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 legallyprotected characteristics.

Primary Work Location: USA CA San Diego TC Bldg C&D. Additional Locations: Work Shift.

At BD, we are strongly committed to investing in our associatestheir wellbeing and development, and in providing rewards and recognition opportunities that promote a performancebased 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 Range Information

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 Fieldbased and Remote roles.

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