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 :
Maintain and ensure compliance with the quality system for supported medical devices.
Support change control activities and provide regulatory consultation for product development.
Offer regulatory direction and interpretation to cross-functional teams.
Prepare U.S. and international regulatory submissions and registration documents.
Handle regulatory activities related to documentation, labeling, and field support.
Demonstrate knowledge of site and division-level policies and procedures.
Terms
12 month contract
On-site in Santa Clara
Pay rate : Up to $80,000 / annually based on years of experience and qualifications