Here are the job position details for your review:

Job Title: Regulatory Affairs Analyst (USC/GC Only & W2 ONLY)
Pay Rate: $50 to $55/HR
Duration: 9 months
Location: Irvine, CA (Onsite)

Shift: 8 am to 5 pm.

We are looking for a Regulatory Affairs Analyst to complete and maintain regulatory approvals and clearances of assigned products.

• Create regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS affiliates; track timelines and document milestone achievements, participate in developing regulatory strategy, prioritize submissions with operating plans as well as ensuring alignment with KOD in countries (e.g., OUS, [the globe minus US, EU, Canada]).
• Participate in representing the OUS regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements resolving conflicts between those requirements and development issues, and/or reporting to management.

Requirements:

• Bachelor's Degree or equivalent in a scientific discipline (e.g., Biology, Microbiology, Chemistry)
• 3-5 years of regulatory affairs or related experience in a medical device, pharma, or a related industry. International regulatory affairs experience is desired
• Excel spreadsheet
• Design history files experience is desired.
• Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices

Job Type: Contract

Pay: $50.00 - $55.00 per hour

Expected hours: 40 per week

Experience level:

• 3 years

Schedule:

• 8 hour shift

Ability to Commute:

• Irvine, CA 92614 (Required)

Ability to Relocate:

• Irvine, CA 92614: Relocate before starting work (Required)

Work Location: In person