Senior Specialist in Regulatory Compliance

2 weeks ago


Sunnyvale, California, United States MyKelly Full time
Position Title: Regulatory Affairs Senior Specialist
Overview:
The Regulatory Affairs Senior Specialist at MyKelly is tasked with assessing and guaranteeing the precision of labeling for in vitro diagnostic products. This role presents a distinctive chance to engage with various cross-functional teams, including Technical Publications, Product Transfer, Quality Assurance, Research & Development, and Clinical Affairs, as part of MyKelly's comprehensive change control process. The position is crucial in ensuring adherence to regulatory standards for product labeling while providing exposure to a wide range of innovative diagnostic products and technologies.
Work Arrangement: Hybrid
Working Hours: Standard business hours, Monday to Friday
Contract Length: 6 months
Compensation: $50 per hour
Key Responsibilities:
  • Process Familiarization: Gain a thorough understanding of MyKelly's global change control procedures.
  • Review and Execution: Analyze change plans and apply modifications to product labeling and instructions for use.
  • Collaborative Engagement: Collaborate with various stakeholders to ensure the accuracy of labeling modifications.
  • Regulatory Adherence: Work alongside the Technical Publications team to produce labeling that complies with regulatory requirements.
Qualifications:
  • Bachelor's degree with a minimum of 5 years of relevant experience, or a Master's degree with at least 3 years of relevant experience, or a Doctoral degree with 0-2 years of relevant experience.
  • Comprehensive knowledge of regulatory affairs principles and familiarity with regulations and guidelines related to diagnostic product development and labeling claims.
  • Understanding of Quality Management System (QMS) regulations and standards.
  • Proficiency in Microsoft Office Suite and Adobe Acrobat.
Preferred Qualifications:
  • Experience in managing labeling controls and change processes.
  • Familiarity with the Corrective and Preventative Action (CAPA) framework.
  • Experience with Agile documentation systems.


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