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BD (Becton, Dickinson and Company) Manager Regulatory Affairs, Labeling (REMOTE) in San Diego, California

Job Description Summary

Job Description

Be part of something bigger!

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. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

Excited to grow your career?

We value our talented employees, and whenever possible strive to help one of our associates grow professionally before recruiting new talent to our open positions. If you think the open position you see is right for you, we encourage you to apply!

Our people make all the difference in our success.

Manager Regulatory Affairs, Labeling is responsible for creating and executing regulatory labeling in alignment with business needs. This includes the preparation of labeling required to market new or modified medical devices in the US, EU, and other geographies, and related regulatory affairs activities, such as development, execution and management of procedures and systems designed to ensure that the product development process, including clinical, non-clinical, and performance evaluation studies, addresses all regulatory requirements as well as the objectives of the business. This position requires to collaborate with other functions (R&D, Quality, Operations, etc.) and external consultants.

Job Responsibilities:

  • Provides regulatory leadership to assigned product development program teams by providing regulatory guidance on labeling compliance, throughout the product development cycle and coordinating team inputs for regulatory submissions.

  • Reviews and approves labels, labeling, and promotional materials.

  • Review’s product design and change documentation, performs regulatory assessments, and implements required regulatory actions.

  • Reviews labeling verification and validation protocols to assure collection of appropriate data for regulatory submissions and regulatory compliance.

  • Consults with internal experts and leadership to identify priority issues to create global labeling plans.

  • Works with business and cross-functional teams to ensure alignment of global regulatory strategies with business objectives and implementation of the strategic plans.

  • Create global regulatory strategies to document labeling compliance.

  • Responsible for writing and updating standard operating procedures (SOP) and work instructions (WI) to support the implementation of US and International labeling regulations.

  • Conduct training on labeling requirements/regulations, new SOP’s and WI’s

  • Identifies and communicates potential risks and mitigations associated with regulatory strategies.

Minimum Qualifications:​

  • Bachelor's degree required, strongly preferred in science and engineering

  • Minimum 5 years’ experience in regulatory affairs in the device/diagnostic industry. MDR experience a plus.

  • Working knowledge of US and International Medical Device Regulatory requirements.

  • Demonstrated experience in authoring labeling for FDA 510(k) and International submissions.

  • Ability to effectively communicate both verbally and in writing to all levels within the organization and external to the organization.

  • Demonstrated ability to interpret and implement new regulations.

  • Demonstrated ability to project manage regulatory labeling projects.

  • Demonstrated ability to prioritize competing priorities and deadlines and organize complex information.

For many 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, weekly testing for COVID-19 may be available instead of vaccination. 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 empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.

To learn more about BD visit https://jobs.bd.com/

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.

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Primary Work Location

USA CA - San Diego TC Bldg C&D

Additional Locations

Work Shift

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.

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.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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