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Exempt / Non Exempt : Non Exempt Years Experience : - years regulatory experience and / or 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, 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 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.
Full Time
$78k-101k (estimate)
04/28/2024
05/03/2024
hire-talent.com
Cedar, MN
<25
The job skills required for Regulatory Specialist II include Chemistry, 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.