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Katalyst CRO

Regulatory Affairs Associate

Katalyst CRO, Santa Clara

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Job Description
Seeking a Regulatory Affairs Associate to support international addendum labelling (IFUs, import labels, and country-specific labeling) for medical devices. This role involves collaboration with global RA teams and ownership of labeling compliance processes.

Job Description
Seeking a Regulatory Affairs Associate to support international addendum labelling (IFUs, import labels, and country-specific labeling) for medical devices. This role involves collaboration with global RA teams and ownership of labeling compliance processes.
Responsibilities

  • Develop and design compliant labeling, including IFUs and international labels.
  • Coordinate cross-functional teams and manage multiple labeling projects.
  • Implement changes per international regulatory guidelines.
  • Fill out forms, revue redlines and submit packages to the labeling team.
  • Track labeling change requests and maintain documentation for audits.
  • Monitor global regulatory trends and update internal procedures.
  • Support quality system improvements and KPI reporting.
Requirements :
  • Bachelor's degree in Regulatory Affairs, Biomedical Engineering, or related field.
  • 4+ years in regulatory/quality operations within a regulated industry.
  • Experience with labeling design, document control, and regulatory submissions.
  • Strong knowledge of FDA and international device labeling regulations.
  • Proficiency in SAP, Adobe Acrobat, and MS Office.
  • Experience with Class III implantable medical devices.
  • Hands-on with PMA supplements, change assessments, and audit preparation.
  • Strong project coordination and stakeholder communication skills.
Seniority level
  • Seniority level
    Associate
Employment type
  • Employment type
    Contract
Job function
  • Job function
    Legal
  • Industries
    Pharmaceutical Manufacturing

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