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Regulatory Compliance Expert

2 months ago

Santa Clara, California, United States GForce Life Sciences Full time

Regulatory Affairs Specialist

Company: GForce Life Sciences

Employment Type: Full-time, 12-month contract

Position Overview: GForce Life Sciences is seeking a knowledgeable regulatory affairs specialist. This role involves establishing and executing regulatory frameworks and priorities in partnership with diverse stakeholders.

Core Responsibilities:

  • Support the development and execution of regulatory frameworks
  • Effectively communicate challenges to management and stakeholders
  • Maintain strong visibility with both internal and external partners
  • Exhibit proficient communication skills
  • Collaborate with internal teams to fulfill regulatory requirements
  • Oversee and monitor strategic initiatives
  • Ensure prompt completion of regulatory frameworks and tasks
  • Convey regulatory necessities to project teams

Required Qualifications:

  • Bachelor's degree in engineering or a scientific discipline; master's degree preferred
  • A minimum of 3 years of experience in regulatory affairs
  • Familiarity with US and/or Canadian regulatory standards
  • Experience in regulatory submissions
  • Capability to negotiate, influence, and resolve conflicts
  • Prior experience in the medical device, food, or pharmaceutical sectors is preferred
  • Proven ability to write clearly and effectively

Contract Details:

  • 12-month contract with potential for extension
  • Full-time, 40 hours per week
  • Onsite position