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Overview

Be part of something bigger at BD. Here, you’ll help us maintain our high standards from a regulatory perspective at all levels, with a keen focus on submissions. It requires acute attention to detail, excellent communication skills and a passion to keep learning and updating your knowledge, which we’ll help you do with regular learning opportunities. Here, you’ll use your in-depth knowledge of FDA, Canadian and ISO/MDD regulations and requirements surrounding medical devices to ultimately achieve a singular goal: advancing the world of health. At BD, you can make a true difference of one.

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Success Profile

What makes a successful Regulatory Affairs Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.

  • Analytical
  • Collaborative
  • Communicator
  • Persuasive
  • Problem-solver
  • Skilled presenter

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A New Era in Healthcare

The complementary nature of BD and CareFusion capabilities make the new, combined company more relevant than ever before. It’s not just the solutions we offer, It’s also where we offer them. The global reach of the combined company can offer new solutions around the world.

Quote

Brian Carney, Staff RA Specialist, BD, Surgical

"The team at BD was exceptionally welcoming and courteous upon arrival on my first day. I was immensely impressed with the passion of my project team members. Positive energy here is contagious… I very much look forward to the coming years with the BD team!"

Robin Cassell, Global Regulatory Operations Labeling Specialist

"I love working with high powered leaders on a day to day basis who are respectful to my opinion and who I was never exposed to in my past job."

Nikita A Mahendra Kumar, Senior Regulatory Affairs Specialist, Medication Delivery Solutions

"I have been trusted in my ability to lead exciting and challenging projects with excellent upper management support. This in-turn has allowed me to grow and expand my regulatory knowledge that I believe will lay as a foundation to build my Regulatory career on."

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Benefits

  • Healthcare

  • Healthcare FSA

  • 401(k) / Retirement Plans

  • Employer Matching

  • Tutition Reimbursement

  • Paid Time Off

  • Location

  • Collaborative Culture

  • Compensation

  • Awards & Recognition

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Responsibilities

Job ID R-367773 Date posted 07/06/2020

Job Description Summary

Job Description

The Sr. Regulatory Affairs Manager  reports directly to the Director of Regulatory Affairs for Molecular Diagnostics and WHC within the  Integrated Diagnostic Solutions business unit. This position is responsible and accountable for developing and executing sound strategies for complex regulatory submissions for functional unit. This position directs multiple projects of their functional teams with limited oversight, provides instruction, guidance, and regulatory interpretations to staff and teams to achieve rapid worldwide clearance/approval/registration of products with desired claims. Proficient project/people management skills, establishes schedules and milestones for functional projects, coaches team on career development, provides performance feedback, recommends on budget staffing/project costs/priorities/metrics. Represents BD in pivotal interactions/negotiations with regulatory agencies, and participates in external efforts to influence policy making bodies and standard development organizations.  The position will be responsible for managing regulatory affairs specialists.

Job Responsibilities:

  • Assesses regulatory pathways for new product platforms and product modifications; develops regulatory strategies and tactical plans for submissions to US FDA and other regulatory agencies.

  • Identifies and communicates potential risks and mitigations associated with regulatory strategies to cross-functional business teams, senior BD Leadership and other stakeholders.

  • Represents BD in interactions/negotiations with U.S. and other global regulatory agencies and enables, coaches and empowers staff to effectively interact and negotiate with regulators.

  • Represents BD in external activities benefiting BD and their respective business group, including trade associations, professional organizations, and standards development organizations.

  • Responsible for monitoring, interpreting, and implementing current and new regulatory requirements for U.S. and EU.

  • Identifies opportunities for continuous improvement that have a significant impact (cost, cycle time, quality, etc.) and assists in developing or executing implementation plan.

  • Manages a staff of regulatory professionals carrying out product submission/registration activities.

  • Manages the preparation and filing of pre-market submissions and Technical Files.

  • Manages the regulatory review of labels, labeling, and promotional materials.

  • Hires, develops and retains staff to meet business needs and creates a pipeline of talented professionals for progressively challenging and responsible roles.

  • Develops direct reports with regard to required competencies, including, but not limited to, regulatory knowledge and ability to apply this knowledge, effectively in cross-functional teams and one-to-one interactions in both verbal and written communications

  • Designs and implements training on regulatory issues for functional staff and for cross-functional groups across BD.

  • Provides recommendations into functional budget as requested.

Minimum Qualifications:

Education and Experience:

  • B.S. degree, or higher, preferably in a technical discipline (biology, microbiology, molecular biology, bioengineering).

  • RAPS RAC (U.S.) preferred.

  • Minimum of 6 years' directly related regulatory experience in the medical device and/or in vitro diagnostic device area(s).

  • Demonstrated experience in interpreting subjective and complex aspects of specific regulations and has thorough understanding of multiple sets of associated regulations.

  • Demonstrates in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes. May be recognized internally as technical or subject matter expert in multiple areas.

  • Demonstrated success in supporting product development and product support projects, including complex projects involving ambiguity and rapid change.

  • Demonstrated success in preparing, filing and completing (including negotiations) regulatory submissions/dossiers (e.g., 510(k), IDE, PMA, Technical Files).

  • Advocacy work with trade associations and coalitions is preferred.

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.

#LI-TECH

Primary Work Location

USA MD - Baltimore

Additional Locations

Work Shift

NA (United States of America)
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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