Overview

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.

Responsibilities:

  • 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)

Qualifications:

  • 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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