Regulatory Affairs Specialist

Regulatory Affairs Specialist II – Santa Clara, CA

Must be able to work on a W2

Job Summary

We're looking for a Regulatory Specialist with 2-5 years of experience in the medical device industry. Your responsibilities include maintaining the quality system, supporting manufacturing operations, and providing regulatory guidance. Experience with international product registrations and electronic document control systems is a plus.

Responsibilities:

Implement and maintain the effectiveness of the quality system

Support manufacturing/operations day-to-day activities for change control

Provide consultation/advice to regulatory specialist for change control and product development

Provide regulatory direction/interpretation on team activities

Interpret and apply regulatory understanding to support products and teams

Prepare U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide

Handle regulatory activities involved in documentation, labeling, field support

Apply regulatory and technical knowledge to a wide variety of complex work assignments

Maintain and ensure compliance to the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supports

Ensure compliance to and demonstrate knowledge of site and division level policies and procedures

Qualifications:

2-5 years regulatory experience and/or 2 years relevant industrial experience typically with a quality, product-development/support, or scientific affairs function

Knowledge of regulations and standards affecting IVDs and/or biologics

BS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc.

Experience with international (outside of EU and US) product registrations preferred

Experience working with medical device operations on control of product release preferred

Experience working with electronic change management/document control systems preferred

Term & Start

6- month contract

FT, M-F 40hr/week

Pay Rate: $50-55/HR (100-110K Annually)

Onsite in Santa Clara, CA