Job Title: Regulatory Affairs Specialist 3
Duration: 10 Months
Location: Irvine, CA 92618 (Hybrid, 3 days onsite, 2 days remote)
 
Job Description:

• 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.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 53.03/hr.