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Regulatory Compliance Specialist

2 months ago

Irvine, California, United States Insight Global Full time

Essential Qualifications:

  • Bachelor's Degree in a relevant field
  • Minimum of 2 years' experience in regulatory compliance or complaint management
  • Proven track record in managing the complete process of complaint resolution (initiation, investigation, and closure)
  • Experience in preparing and submitting documentation to the FDA
  • Familiarity with Good Manufacturing Practices (GMP) and US Federal Regulations CFR 820 & 803
  • Background in medical device industry

Preferred Qualifications:

  • Knowledge of FDA eSubmitter and/or WebTrader platforms

Responsibilities:

A manufacturing organization is looking for a temporary Regulatory Compliance Specialist to support their operations. This role involves assessing incidents to ascertain whether they qualify as complaints and if they require reporting to the FDA. The individual will engage directly with clients and ensure adherence to all regulatory standards. This position offers a hybrid work model, requiring onsite presence three days a week.

Compensation ranges from $25 to $35 per hour.

Compensation may vary based on various factors, including skills, experience, and educational background.

Benefits for this position will commence on the 31st day of employment and include medical, dental, and vision coverage, as well as options for HSA, FSA, and DCFSA accounts, and access to a 401k retirement plan with employer matching. Employees in this role are also eligible for paid sick leave and/or other paid time off as mandated by applicable law.