Regulatory Compliance Expert

2 weeks ago


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

Regulatory Affairs Specialist

Location: Santa Clara, CA

Employment Type: Full-time, 12-month contract

Overview: GForce Life Sciences is seeking a skilled regulatory affairs specialist to contribute to our mission in the medical device sector. The successful candidate will play a crucial role in shaping and executing regulatory strategies in partnership with diverse teams.

Key Responsibilities:

  • Support the development and execution of regulatory strategies
  • Effectively communicate challenges to management and stakeholders
  • Maintain visibility with both internal and external partners
  • Exhibit strong communication capabilities
  • Collaborate with internal teams to fulfill regulatory requirements
  • Oversee and monitor strategic initiatives
  • Ensure the timely execution of regulatory strategies and tasks
  • Convey regulatory obligations to project teams

Qualifications:

  • Bachelor's degree in engineering or a scientific discipline; master's degree preferred
  • At least 3 years of experience in regulatory affairs
  • Familiarity with US and/or Canadian regulatory frameworks
  • Experience in regulatory submissions
  • Proven ability to negotiate, influence, and resolve conflicts
  • Previous experience in the medical device, food, or pharmaceutical sectors is advantageous
  • Demonstrated proficiency in written communication

Terms:

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


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