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BD (Becton, Dickinson and Company) Sr. Regulatory Affairs Specialist (Remote Optional) in Warwick, Rhode Island

Job Description Summary

Job Description

The Sr. RA Specialist will develop a regulatory strategy for worldwide marketing. This role is responsible for completing all regulatory marketing submissions. This role will participate in the creation of design control and clinical study planning.

Manage regulatory projects to ensure timely introduction of new products subject to medical device regulations in U.S. and global regions. Provide technical and administrative regulatory support to marketed products and ensure company’s regulatory compliance status.

This position is a temporary assignment which will include benefits such as (medical, health, dental, 401k). Eligibility for these benefits will be based on the eligibility requirements as determined by the BD Total Rewards policy, and is anticipated to last approximately through September 30, 2023.

Essential Duties and Position Responsibilities

  • Prepare and submit applications to the FDA for clinical testing and marketing of new/modified medical devices (e.g., 510(k)’s, IDE’s, PMA’s, PMA supplemental applications)

  • Support in determination of the appropriate regulatory submission requirements and strategies for new or modified products. Prepare required documentation as needed (e.g., No 510(k) Rationales, international change notifications).

  • Coordinate review of FDA submissions and test protocols with Corporate Regulatory, Medical and Legal Departments, and respond to any questions posed by these departments or the FDA.

  • Prepare application documentation for international marketing approvals (i.e. EU MDR Technical Documents, JSTD, International Dossier).

  • Assist Product Development and Quality Assurance in planning pre-clinical studies and bench testing that will ultimately be used in regulatory submissions.

  • Assist in the review of proposals for clinical design validations, clinical field trials and customer preference tests.

  • Represent regulatory affairs on product development teams to provide direction with respect to regulatory/clinical requirements and strategy.

  • Assist in development of new product instructions for use/promotional material. Review product labeling for compliance with medical device regulations and Division/Corporate Policies.

  • Provide marketed product regulatory support for change management activities, product registrations, and business improvement activities.

  • Support due diligence and business integration activities as assigned.

  • Support the development and implementation of BD regulatory processes, procedures, and standards as assigned.

Qualifications, Knowledge, and Skills Required:

  • B.S. or equivalent with emphasis on Life Sciences.

  • Professional certifications and advanced degree preferred.

  • Knowledge and experience (5+ years) with regulatory requirements for medical devices and / or combination products (IDE’s, PMA’s ,510(k)’s, CE mark technical files and design dossiers).

  • Good oral and written communications skills - analytical thinking and technical writing; ability to work on cross-functional teams; ability to manage several parallel deliverables.

  • Working knowledge of statistics and electronic documentation and information systems.

  • Ability and desire to travel as needed.

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 LocationUSA RI - Warwick

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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.

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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