Regulatory Compliance Expert

2 weeks 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

Overview: GForce Life Sciences is seeking a skilled regulatory affairs specialist. This role involves the formulation and execution of regulatory strategies in partnership with diverse stakeholders within the medical device sector.

Key Responsibilities:

  • Develop and implement regulatory strategies
  • Effectively communicate regulatory challenges to management and stakeholders
  • Maintain visibility with both internal teams and external partners
  • Exhibit strong communication skills
  • Collaborate with internal departments to fulfill regulatory requirements
  • Oversee and monitor strategic projects
  • Ensure timely execution of regulatory initiatives
  • Relay regulatory requirements to project teams

Qualifications:

  • Bachelor's degree in engineering or a scientific discipline; a master's degree is preferred
  • At least 3 years of experience in regulatory affairs
  • Familiarity with US and/or Canadian regulatory frameworks
  • Experience in preparing regulatory submissions
  • Strong negotiation, influence, and conflict management skills
  • Prior experience in the medical device, food, or pharmaceutical sectors is advantageous
  • Proven ability to write clearly and effectively

Terms:

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


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