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

Job Description SummaryRegulatory Affairs Specialist will be responsible for the preparation of regulatory submissions and documentation required to market new or modified medical devices and in vitro diagnostic devices in both domestic and international clinical markets. This responsibility entails development, execution and management of procedures and systems designed to ensure that the product development process, including analytical and clinical studies, addresses applicable regulatory requirements as well as meets the objectives of the business.

Job Description

  • Understands and is able to interpret U.S. and international medical device and in vitro diagnostic device (IVD) regulatory requirements, statutes, regulations, policies and guidance.

  • Participates on cross-functional product development teams to ensure the business is positioned to meet strategic corporate goals.

  • Provides guidance on regulatory requirements to product development teams to facilitate compliance and develops effective strategies for regulatory submissions / documentation.

  • Assesses regulatory pathways for new product platforms and product modifications Identifies and communicates potential risks and mitigations associated with regulatory strategies to stakeholders.

  • Prepares regulatory submissions (510(k), Technical Files and other regulatory documentation) for product clearance/registration as required by the US FDA and international government agencies, including requisite pre-submissions and post-market approval reports.

  • Assists in the planning and design of internal studies (including feasibility studies), premarket clinical studies and post-market studies in support of US FDA and international regulatory submissions, as required.

  • Assists in the regulatory review of labels, labeling, advertising and promotional materials.

  • Remains current on regulatory issues/trends affecting business unit products, assessing and communicating their impact to RA colleagues, product development/support teams, and to others in the business.

  • Maintains proactive and positive working relationships with internal and external customers, both US and Ex-US, to ensure the business is positioned to meet strategic corporate goals.

  • Is able to manage and monitor multiple and/or diverse projects simultaneously, including projects that involve several functional areas.

Qualifications:

  • Bachelor’s degree or advanced degree, preferably in a scientific discipline, health sciences, or engineering.

  • Minimum 3 or more years of regulatory experience in the medical device and/or in vitro diagnostic device area(s).

  • Working knowledge of medical device and/or in vitro diagnostic device regulations.

  • Experience in the process for preparing and filing a 510{k} submission and preparing regulatory documentation.

  • Prefer experience in preparing and maintaining EU Technical Files.

  • Experience supporting product development and/or product support projects.

  • Demonstrated ability to effectively communicate both verbally and in writing.

  • Successful history of handling multiple projects, and prioritizing / scheduling activities and managing deadlines.

  • Experience maintaining confidential information at appropriate levels within an organization.

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Primary Work LocationUSA NJ - Franklin Lakes

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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