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Regulatory Compliance Specialist

2 months ago


Redondo Beach, California, United States MyKelly Full time
Regulatory Affairs Specialist Focused on Labeling
Location: Redondo Beach, 100% onsite
Shift: M-F, standard working hours
Pay: $40-$45/hr
Temp to Hire

Key Responsibilities:
  • Collaborate with Global/Platform Regulatory Affairs, Research & Development, Clinical teams, and cross-functional partners to ensure adherence to regulatory standards.
  • Facilitate discussions and partnerships to evaluate new health authority regulations.
  • Support intricate projects, make informed decisions, and foresee regulatory challenges.
  • Engage with Subject Matter Experts to gather essential information for regulatory submissions.
  • Assist in the maintenance of global product registrations and audits.
  • Prepare documentation for regulatory submissions and oversee FDA Certificates to Foreign Government.
  • Initiate investigations for non-conformities and implement CAPA/SCAR processes.
Qualifications:
  • Bachelor's degree in a relevant field.
  • 3-5 years of experience in regulatory affairs within the medical device sector.
  • Familiarity with various jurisdictions including EU, US, and Asia.
  • Experience with EU MDR technical documentation.
  • Basic project management capabilities.
  • Regulatory Affairs Certification is preferred.