Regulatory Affairs Specialist - Hercules CA (Ivd Medical Device Industry Experience Required)

Advantage Technical is seeking a RA Specialist for our client in Hercules, CA. This is for a top-five life science company in the world! Do you have what it takes?

Contract Length: 12 months

Pay: $30-40/hr

Schedule: Hybrid after 30 days; Monday and Tuesday onsite, the 3rd onsite will be candidate's choice; 8am-4:30pm with flexibility in the schedule

Requirements: Experience in IVD medical device industry a MUST

• Provide regulatory support for IVD products with multiple product groups within clinical diagnostics.

• Work with regulatory database to post Instructions for use.

• Assembles low complexity regulatory submissions to support worldwide product registration.

• Basic analytical, communication, problem solving, critical thinking, and database management to meet daily job responsibilities.

• Interface daily with desktop publisher, technical writers and Regulatory Affairs Specialists. Work collaboratively with Marketing, R&D, QA, Planning, and Manufacturing teams.

How You'll Make An Impact:

• Strong prioritization skills, flexibility and ability to handle multiple projects simultaneously while meeting deadlines

• Ability to communicate effectively with employees across multiple departments

• Highly organized and detail-oriented. Good time management.

• Technical aptitude for understanding IVD product features

What You Bring:

• Education: BS in Biology with emphasis in biology.

• Work Experience: 0-2 years experience in IVD regulatory affairs.

• Proficient use of MS Office applications (e.g., Excel, Word, PowerPoint, Teams)

• Laboratory research experience in an IVD medical device regulated environment.

The base pay range above represents the low and high end of the base compensation range we reasonably expect to pay for this position. Actual base compensation will vary and may be above or below the range based on various factors including, but not limited to, geographic location, actual experience, and job performance. This job posting is not a promise of any specific pay for any specific employee.

The range listed is just one component of the total compensation package for our employees. Based on the details of your position, we provide a variety of benefits to our employees, including medical, dental, and vision plans, pre-tax savings plans, pre-tax parking and commuter plans, supplemental health and welfare plans, a retirement savings plan, an employee assistance program, pet insurance, and paid holidays. Other rewards may include short-term incentives and paid time off.

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