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Regulatory Compliance Specialist

2 months ago


Redondo Beach, California, United States Kelly Science, Engineering, Technology & Telecom Full time

Position: Regulatory Compliance Specialist with Expertise in Labeling

Location: Redondo Beach, CA - Onsite Role

Work Schedule: Monday to Friday, standard hours

Compensation: $40-45 per hour

Employment Type: Temporary to Permanent

Key Responsibilities:

  • Facilitates discussions with Global/Platform Regulatory Affairs, Research & Development, Clinical teams, and other relevant partners to ensure that regulatory requirements for China are clearly understood and integrated early in the product development lifecycle.
  • Leads necessary discussions and collaborations to evaluate new or updated health authority regulations specific to China.
  • Provides support for complex projects, making timely and effective decisions based on available data to meet project objectives, especially in ambiguous situations.
  • Collaborates with other departments and Subject Matter Experts (SMEs) to gather necessary information and data for regulatory submissions.
  • Identifies potential regulatory challenges and emerging issues throughout the product lifecycle, developing proactive solutions.
  • Contributes to the maintenance of global product registrations, including EU MDR Technical Documentation and Global Submission Summary Documents.
  • Participates in the preparation for and execution of internal and external regulatory audits.
  • Assembles materials required for new global product submissions, license renewals, and modification submissions.
  • Requests, acquires, and maintains FDA Certificates to Foreign Government (CFGs), including notarization and legalization, as well as EC/ISO certificates and other regulatory documents.
  • Initiates investigations into non-conformances driven by translation vendors and oversees CAPA/SCAR investigations.

Qualifications:

  • Bachelor's degree in a relevant field
  • 3-5 years of direct experience in regulatory affairs within the medical device sector
  • Familiarity with multiple regulatory jurisdictions, including EU, US, and Asia, particularly in labeling and regulatory submissions.
  • Experience with EU MDR technical documentation
  • Proven ability to manage tasks or projects, with basic project management skills.
  • Regulatory Affairs Certification is preferred but not mandatory.