This position is responsible for management of regulatory databases, provides product technical expertise, as well as assisting RA management in regulatory activities, including assessments, strategies and technical file maintenance.


  • Manage regulatory databases (UDI, products, technical files, etc.)
  • Research technical requirements for regulatory databases
  • Assist in technical interface between regulatory specialist and labeling specialist
  • Provide guidance on UDI labeling requirements as subject matter expert
  • Manage the technical file organizers in Master Control per guidelines
  • Assist in preparation of regulatory submissions (510(k)s, technical files, design dossiers)


  • Must be able to maintain confidentiality in dealing with regulatory and clinical documentation
  • Strong interpersonal skills in the areas of written and verbal communication
  • Must be a team player
  • Must be able to prioritize and handle multiple projects concurrently
  • Must be self-motivated, work independently and have the ability to work with minimal supervision
  • Must be computer literate, proficient in Master Control, desired
  • Must be able to meet goals on time
  • Must have be able to research technical topics (product materials and attributes)

Education and/or Experience:

  • AS Degree required; BS/BA preferred
  • Five years experience in medical device/FDA regulated industry
  • Regulatory Affairs Certification (RAC) desired

To apply for this job please visit the following URL: https://jobs.bd.com/job/-/-/159/6651853?apstr=src=JB-10300 →

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