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Regulatory Specialist - 62639871 - TV

Job Code: 62639871
Job Location: Miami, FL
Category: Business
Last Updated: 07/13/2018
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Job Description:
Integrates regulatory strategies and programs to support new product development and commercial product maintenance. As a regulatory process expert to development teams, the incumbent support global registrations and compliance activities; provides regulatory review of promotional material, experimental designs, data analysis and product labeling as related to registration and commercialization of medical devices; collaborates with the regulatory staff from other business units, companies, government agencies and Product Regulatory Subcommittees to develop harmonized policies, procedures and work instructions for emerging regulatory topics
 
Requirements:
• Bachelor’s degree (or foreign equivalent) in Science, Regulatory Affairs, or Engineering plus 3 years of experience in the offered position.
• Experience implementing premarket regulatory strategy.
• Experience writing and submitting premarket submissions to regulatory agencies.
• Experience preparing submissions for FDA establishment registrations, Canadian site license renewals, US State licenses and USDA licenses.
• Experience applying 21 CFR 801, 803, 806 and 820 regulations.
• Experience communicating with regulatory agencies including FDA, Health Canada and EU regulatory agencies and responding to agency inquiries.
 
For more information about this position, please contact the Entegee New Hope, MN office at 763-577-9000 or engineeringteam@entegee.com.
 
Please reference job # 62639871TV
 
Equal Opportunity Employer
Minorities/Women/Veterans/Disabled
 

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Entegee is an equal opportunity employer. Entegee considers applicants for all positions without discrimination on the basis of race, color, religion, sex, national origin, age, marital or veteran status, disability, or any other legally protected status. No question in the website is used for the purpose of limiting or excluding any applicant's consideration for employment on any basis prohibited by local, state, or federal law.

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