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Regulatory Specialist II
Santa Clara, CA
Job Description
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:
SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at nahr@spectraforce.com if you require reasonable accommodation.
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.
- 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.
SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at nahr@spectraforce.com if you require reasonable accommodation.
Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Experience
2 to 5 years
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