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BD (Becton, Dickinson and Company) Regulatory Affairs Specialist in Franklin Lakes, New Jersey

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.

About the role:

The Regulatory Affairs Specialist will work in BD Medical - Pharmaceutical Systems Business Unit focusing on self-injection devices and safety systems. Under the guidance of the Manager or Staff RA Specialist, the position will provide technical and administrative regulatory support to ensure timely new product launches or product changes in U.S. and global regions. Additionally, this position will provide regulatory support to marketed products and monitor regulatory intelligence impacting product compliance.

Key responsibilities will include:

  • Support for Pharmaceutical Systems regulatory projects in a continuous effort to adapt the activity as closely as possible to the needs of the pharmaceutical industry

  • Coordinate and prepare new regulatory documents (master file, technical file) and updates in a timely manner

  • Coordinate and collect specific product or technical information with R&D, QA, RA, Medical Affairs and other applicable departments as necessary to support regulatory documents

  • Support regulatory documents and registrations as it related to product changes, new product launches and/or product renewals

  • Support RA with customer and technical inquiries (post market)

  • Regulatory intelligence for GPDS support

  • Perform other tasks as assigned

About you:

To be successful in this role, you require

  • Knowledge of regulations for pharmaceutical drug products, medical devices or drug-device combination products

  • Understanding of product development cycle, change control, quality systems

  • Ability to adapt and respond quickly in a constantly evolving and often ambiguous environment

  • Strong team spirit, integrity mentality

  • Strong customer centric mentality (internal and external)

Education and experience required:

  • B.S. or B.A. degree in a technical field (e.g., engineering, biology, chemistry).

  • Minimum 3 years of directly related professional experience (Regulatory, Quality, Compliance)

  • RAPS certification a plus.

Click on Apply if this sounds like you!

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 NJ - Franklin Lakes

Additional Locations

Work Shift

US BD 830am-5pm FLakes Core Hours (United States of America)

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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