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Regulatory Specialist II - Santa Clara, United States - DivIHN Integration
Description
Job DescriptionJob Description
For further inquiries regarding the following opportunity, please contact one of our Talent Specialists
Rashi at
Divya at
Title:
Regulatory Specialist II
Location:
Santa Clara, CA
Duration: 6 Months
Description:
Exempt/Non Exempt:
Non Exempt Years
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.Experience :
2-5 years regulatory experience and/or 2 years relevant industrial experience typically with a quality, product- development/support,
or scientific affairs function.
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.
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.
About us:
DivIHN , the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond.
DivIHN is an equal opportunity employer.
DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.
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