Regulatory Specialist II - Santa Clara, United States - Spectraforce Technologies

Spectraforce Technologies Santa Clara, United States

3 weeks ago

Description

Job Title: Regulatory Specialist II

Duration: 6+ Months

Location: Santa Clara, CA

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

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