Sr. Regulatory Affairs Specialist/Regulatory Affairs Lead

Company: Real Staffing
Location: Irvine
Posted on: September 18, 2022

Job Description:

Sr. Regulatory Affairs Specialist/Regulatory Affairs Lead (RE-33923537) Location:Irvine, California, United States Salary:Up to US$100 per hour + competitive, health, dental, vision, 401k, PTO

• Bachelors, masters, or equivalent is preferred.
• Minimum 6 years medical device industry experience, with at least 3 years exposure to regulatory affairs.
• Demonstrated track record in:
  • Submission of licenses and authorizations for new medical device products is required
  • International registrations and technical file preparation is required
  • Previous experience with digital/software/robotic technologies is preferred
  • Execution of regulatory strategies that align with business deliverables is required
  • Knowledge of US Regulations, EU MDR, and China is required
  • Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely varied audience the regulatory or quality function
  • Ability to work well under deadlines and pressure.
  • Excellent written and communication skills, fluency in English.
  • Good judgement/decision making and problem-solving ability, capable of understanding the impact of decision making.
  • Motivated and an enthusiastic self-starter with the ability to work under own initiative and as a team player.EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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