7 regulatory specialist ii Jobs in santa clara, ca
Divihn Integration is Hiring a Regulatory Specialist II Near Santa Clara, CA
Visit us at https://divihn.com/find-a-job/ to learn more and view our open positions.
Please apply or call one of us to learn moreFor further inquiries regarding the following opportunity, please contact one of our Talent Specialists
Rashi at (630) 847-1027
Divya at (224) 369-2969Title: Regulatory Specialist II
Location: Santa Clara, CA
Duration: 6-7 MonthsDescriptionExempt/Non Exempt:Non Exempt Years
DutiesResponsible 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.
Experience2-5 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.
SkillsKnowledge of regulations and standards affecting IVDs and/or biologics.
EducationBS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc.
About UsDivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.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.
Job Summary
Full Time
Business Services
$99k-128k (estimate)
05/27/2024
10/29/2024
divihn.com
HOFFMAN ESTATES, IL
50 - 100
2002
Private
ROOPA RAJESH
$10M - $50M
Business Services
Related Companies
The job skills required for Regulatory Specialist II include Chemistry, Consulting, etc. Having related job skills and expertise will give you an advantage when applying to be a Regulatory Specialist II. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Regulatory Specialist II. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Regulatory Specialist II positions, which can be used as a reference in future career path planning. As a Regulatory Specialist II, it can be promoted into senior positions as a Regulatory Affairs Specialist III that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Regulatory Specialist II. You can explore the career advancement for a Regulatory Specialist II below and select your interested title to get hiring information.
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