Senior Regulatory Affairs Specialist - Onsite

Senior Regulatory Affairs Specialist – Onsite (Urgent Need)

Location:

Irvine, CA

Client:
Medical Devices Company

Duration: 10 Months;
Total Hours/week: 40;
Shift: 1st Shift;
Hybrid onsite 3 days.

Employment Type:

Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)

Job Category:
Clinical;
Level of

Experience:

Mid-Level.

• 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 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.