Regulatory Affairs Analyst

2 weeks ago


Santa Clara, United States Select Source International Full time
Job DescriptionJob Description

Tittle: Regulatory Specialist II

Location: Santa Clara California 95054

• 2 years regulatory experience preferably with medical devices:
• Knowledge of regulations and standards medical devices.
• 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 on market support in terms of 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 and EU regulatory submissions and/or registration documents for international affiliates and government agencies worldwide.
• Handles regulatory activities involved in documentation, labeling, field support.

 

Description:

Exempt/Non Exempt: Non Exempt 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.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.

Company DescriptionSelect Source International (SSI) is an IT, Health Care, and Engineering Services consulting firm that has been in business since 1998. SSI consultants have provided exceptional services that have been appreciated by clients, customers, and users alike at several large Fortune 500 companies, mid-size enterprises, and consulting companies.Company DescriptionSelect Source International (SSI) is an IT, Health Care, and Engineering Services consulting firm that has been in business since 1998. SSI consultants have provided exceptional services that have been appreciated by clients, customers, and users alike at several large Fortune 500 companies, mid-size enterprises, and consulting companies.

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