IVD Regulatory Affairs Specialist I — Hybrid Contract

Tucker Parker Smith Group (TPS Group); Hercules (CA); Hybrid; USD 55,104; Full time

Job summary

A leading biotech and medical manufacturing company in Hercules, CA is looking for a Regulatory Affairs Specialist I. This entry-level role involves supporting global product registration for IVD devices, ensuring compliance with regulations, and collaborating with Marketing, R&D, and QA teams. Required qualifications include a Bachelor's degree in Biology and 1+ years in IVD regulatory affairs. This job offers a hybrid work model and a competitive pay of $40/hr.

Qualifications

• 1+ years in IVD regulatory affairs is required.
• Laboratory research experience in an IVD environment is strongly preferred.
• Familiarity with scientific reports, risk management, and Quality Systems is essential.

Responsibilities

• Assemble regulatory submissions for IVD products across multiple product groups.
• Maintain IVDR technical files and monitor change requests.
• Support SOP improvements tied to IVDR transition.

Skills

IVD regulatory affairs

Laboratory research experience

Proficiency in MS Office

Education

Bachelor's degree in Biology or a related field

Job description

A leading biotech and medical manufacturing company in Hercules, CA is looking for a Regulatory Affairs Specialist I. This entry-level role involves supporting global product registration for IVD devices, ensuring compliance with regulations, and collaborating with Marketing, R&D, and QA teams. Required qualifications include a Bachelor's degree in Biology and 1+ years in IVD regulatory affairs. This job offers a hybrid work model and a competitive pay of $40/hr.