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Regulatory Affairs Assistant

2 months ago

Carlsbad, United States Ultimate Staffing Full time

Local medical device manufacturing company seeking administrative support in their Regulatory Affairs department.

  • Submit change notification
  • Update Technical Documentation for address and manufacturing changes
  • Work cross functionally to draw up details of manufacturing and address changes
  • Track and follow-up communication with all international Distributors and Authorized Reps
  • Update international licenses as required by international Distributors and Authorized Reps
  • Review and approve Change Orders regarding manufacturing and address changes for both businesses
  • Submit Label Checklists to labeling team
  • Track and follow-up communication of changes

Knowledge/skills;

  • Previous medical device experience in a Regulatory Affairs capacity
  • Must be familiar and comfortable using Office 365
    • Mainly Outlook, Word, Excel and Access is a bonus
  • Must work independently and productively with minimal supervision
  • Self-Motivated and team player


All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. To the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.