Regulatory Specialist II

Job Title : Regulatory Specialist II

Duration : 6+ Months

Location : Santa Clara, CA (95054)

Shift : 9 am - 5 pm

Summary :

Seeking candidate with experience with international (outside of EU and US) product registrations; experience working with medical device operations on control of product release;

experience working with electronic change management / document control systems.

Duties :

• Responsible for implementing and maintaining the effectiveness of the quality system. Supports manufacturing / operations day to day activities for change control.
• Provides consultation / advice to regulatory specialist for change control and product development.
• Provides regulatory direction / interpretation on team activities. Interprets and applies regulatory understanding to support of products and teams.
• Prepares U.S. regulatory submissions and / or registration documents for international affiliates and government agencies worldwide.
• Handles regulatory activities involved in documentation,labeling,field support.
• Applies regulatory and technical knowledge to a wide variety of complex work assignments.
• Maintains and ensures compliance to the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supports.
• Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.

Years Experience :

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

Skills :

Knowledge of regulations and standards affecting IVDs and / or biologics

Education :

• BS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc.
• Note : The Company is committed to complying with the California Consumer Privacy Act ("CCPA") effective January 1, 2020;

and all data privacy and laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website .

Applicants with disabilities may access this notice in an alternative format by contacting [email protected] .