Regulatory Affairs Specialist - Onsite

Regulatory Affairs Specialist - Onsite (Urgent Need)

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• Location: Irvine, CA
• Duration: 10 Months
• Total Hours/week: 40.00
• Shift: 1st Shift
• Client: Medical Devices Company
• Job Category: Clinical
• Level of
  
  Experience:
  
  Mid-Level
• Employment Type: Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)
• Hybrid onsite: 3 days
• Salary: $69,510.00-$
• Posting date: 3 days ago

• Regulatory Affairs is responsible for planning, coordinating and implementing regulatory submissions for products that require government approval.
• Demonstrates working knowledge of healthcare-related regulations.
• Demonstrates in-depth knowledge of preparing a submission.
• Demonstrates in-depth knowledge of industry and competitive products.
• Applies relevant regulations and statutes to further product submissions of basic to medium complexity.
• Contributes to the strategic direction of regulatory pathway development.
• Refines and conforms the preliminary data used in the submission process.
• Translates technical data and descriptions into reviewer-friendly content.
• Helps to ensure that the appropriate regulatory requirements for the submission are met.
• Interacts with regulatory body to help further product approvals or clearance.
• Has in-depth experience, knowledge and skills in own job family.
• Applies knowledge and skills to a wide range of standard and non-standard situations.
• Works independently with minimal guidance.
• Usually determines own work priorities.
• Acts as a resource for colleagues with less experience.