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Sr. Regulatory Affairs Specialist, Labeling

Apply Now Job ID R-310008 Date posted 05/23/2018

Job Description Summary

Job Description

The Senior Regulatory Affairs (RA) Specialist is responsible for oversight of global clinical product labeling. This position will work and collaborate with various departments to establish strategy, structure, communicate requirements and approve labeling documents within the organization. He/she is responsible for assisting the Senior Director RA to help champion labeling best practices and continuous improvement projects that are corporate-wide or business driven.

Job Responsibilities:

  • Subject matter expert (SME) for global labeling requirements for clinical products with the focus on US and EU.
  • Establish labeling strategy and requirements for BDB products.
  • Review and approves product labeling for clinical reagents, instruments and software consisting of labels, package inserts, user manuals, and read-me files.
  • Assists in leading regulatory training on labeling requirements including advertising promotional material.
  • Represent BDB in corporate labeling projects and lead BDB labeling projects (e.g., UDI, e-IFU, VeevaVault). Supports various product labeling initiatives to improve overall efficiency and continuity.
  • Approves labeling to ensure compliance with corporate, regulatory, safety and legal requirements.
  • Demonstrates continuous pursuit of regulatory knowledge to obtain experience and expertise in regulatory topics.
  • Performs other duties and assignments as required

Minimum Qualifications:

Educaton and Experience:

  • Minimum of a Bachelor’s degree in life science or engineering field. 
  • Minimum of 3 years' experience in an IVD or medical device organization.
  • Project management certifications or regulatory/quality certifications (RAC, CQA, CQM, etc.) encouraged.

Knowledge and Skills:

  • Working knowledge of FDA 21 CFR 820, ISO 13484 and EU IVD regulations (IVDR).
  • Experience developing labeling strategy for clinical products
  • Demonstrated strong organizational and planning skills, including action-oriented, focused urgency  
  • Attention for details and driving for results.
  • Demonstrated self-starter, learning agility, with multi-tasking skills, problem solving and prioritization skills.
  • Experience working in cross functional programs, strong interpersonal skills with ability to foster
  • collaboration among team members.
  • Computer literacy (SAP, Microsoft Word/Excel/PowerPoint)


Primary Work Location

USA CA - San Jose

Additional Locations

Work Shift

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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.

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