Temporary Jobs in Simi valley ca

Job Title : Regulatory Specialist II On-site in Santa Clara, CA

Must be able to work on a W2

Job Summary :

The Regulatory Specialist II is responsible for implementing and maintaining the effectiveness of the quality system for medical devices. This role supports day-to-day manufacturing and operations activities, including change control and product development. The position requires preparing regulatory submissions for the U.S. and international affiliates, handling regulatory activities such as documentation, labeling, and field support, and ensuring compliance with relevant standards and policies.

Qualifications :

• Bachelor’s degree in a technical discipline (Biology, Chemistry, Microbiology, Immunology, Medical Technology, etc.) preferred.
• Minimum of 2 years of regulatory experience, preferably with medical devices.
• Knowledge of regulations and standards impacting IVDs, biologics, and medical devices.
• Strong understanding of quality systems and regulatory compliance.

Key Responsibilities :

Terms