Regulatory Affairs Specialist

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

Overview

Regulatory Affairs Specialist I - Clinical Diagnostics (IVD) — Hercules, CA 94547 | Hybrid (2 days on-site + 1 flexible day after 30 days) | $40/hr | 6-Month Contract - high potential to extend or convert

Join a top-tier biotech and medical manufacturing company at the forefront of clinical diagnostics. The Regulatory Affairs Specialist I will support global product registration and IVDR compliance for in vitro diagnostic (IVD) devices. You will collaborate cross-functionally with Marketing, R&D, QA, and Manufacturing teams to ensure products meet regulatory requirements worldwide. Experience in the IVD industry is essential to support technical documentation, SOP improvements, and global submissions across multiple diagnostic product lines.

What You'll Do

• 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
• Communicate daily with technical writers, publishers, and regulatory teams

What You Bring

• Bachelor's degree in Biology or a related scientific field
• 1+ years in IVD regulatory affairs
• Laboratory research experience in an IVD medical device regulated environment is strongly preferred
• Familiarity with scientific reports, risk management, and Quality Systems
• Proficiency in MS Office and comfort working in electronic systems (e.g., Excel, Word, PowerPoint, Teams)

Seniority level

• Entry level

Employment type

• Contract

Job function

• Quality Assurance and Research

Industries

• Biotechnology Research
• Medical Equipment Manufacturing
• Pharmaceutical Manufacturing