Regulatory Specialist

Regulatory Specialist

  Not Disclosed

  Santa Clara, CA

  6.5 Months

  Not Disclosed

  Not Disclosed

  Healthcare

  $48.57/hour - $53.57/hour

Job Description

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.

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.

Additional Information:

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.


Note:
9:00AM - 5:00PM
VIVA is an equal opportunity employer. All qualified applicants have an equal opportunity for placement, and all employees have an equal opportunity to develop on the job. This means that VIVA will not discriminate against any employee or qualified applicant on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.