RA Specialist I at Manpower

Regulatory Support Specialist

Our client, a leading organization in the healthcare industry, is seeking a Regulatory Support Specialist to join their team. As a Regulatory Support Specialist, you will be an integral part of the Regulatory Affairs department supporting clinical diagnostics and IVD product registration processes. The ideal candidate will demonstrate strong analytical skills, effective communication, and a proactive approach to problem-solving, which will align successfully in the organization.

Job Title: Regulatory Support Specialist

Location: Hercules, CA

Pay Range: $32.00 to $35.00

Shift: 6am-3:30pm

What's the Job?

• Provide regulatory support for IVD products across multiple product groups within clinical diagnostics.
• Assemble low to medium complexity regulatory submissions to support worldwide product registration and change requests for IVDR compliance.
• Collaborate daily with desktop publishers, technical writers, and regulatory specialists to ensure accurate documentation.
• Work closely with R&D, QA, Planning, and Manufacturing teams to facilitate regulatory processes and product development.
• Utilize analytical, communication, and critical thinking skills to meet daily responsibilities and project deadlines.

What's Needed?

• Bachelor's degree in Biology or a related scientific field.
• 6 months to 2 years of experience in IVD regulatory affairs or related environment.
• Proficiency in MS Office applications such as Excel, Word, PowerPoint, and Teams.
• Understanding of scientific reports, risk management, and Quality Systems.
• Technical aptitude for understanding IVD product features and familiarity with databases and electronic systems.

What's in it for me?

• Opportunity to work in a dynamic and innovative healthcare environment.
• Engagement with diverse teams and cross-functional collaboration.
• Development of regulatory expertise in a growing industry sector.
• Contributing to the advancement of clinical diagnostics and patient care.
• Potential for career growth within a reputable organization.

Upon completion of waiting period, associates are eligible for:

• Medical and Prescription Drug Plans
• Dental Plan
• Supplemental Life Insurance
• Short Term Disability Insurance
• 401(k)