Regulatory Affairs - Specialist

Regulatory Affairs Specialist - Onsite (Urgent Need)

Location:

Irvine, CA | Contract Duration: 9 months | Salary: $69,510.00 - $

Locals Only - Onsite in Irvine, CA (Hybrid)

• Planning, coordinating, and implementing regulatory submissions for products requiring government approval.
• Demonstrated working knowledge of healthcare-related regulations.
• In-depth knowledge of preparing a submission and understanding of industry and competitive products.
• Application of relevant regulations and statutes to further product submissions of basic to medium complexity.
• Contributing to the strategic direction of regulatory pathway development.
• Refining and conforming the preliminary data used in the submission process.
• Translating technical data and descriptions into reviewer-friendly content.
• Ensuring that the appropriate regulatory requirements for the submission are met.
• Interacting with regulatory bodies to help further product approvals or clearance.
• In-depth experience, knowledge, and skills in own job family.
• Applying knowledge and skills to a wide range of standard and non-standard situations.
• Working independently with minimal guidance and usually determining own work priorities.
• Acting as a resource for colleagues with less experience.

In-depth experience, knowledge, and skills in the regulatory affairs job family, including the ability to work independently and act as a mentor to less experienced colleagues.