Regulatory Compliance Supervisor

3 weeks ago


Tucson, United States Job Juncture Full time
Job Description

Seeking an experienced Regulatory Compliance Supervisor with experience in manufacturing process controls in medical device/plastics environment.  You will be responsible for medical device regulatory requirements; 21 CFR Par 11, 21 CFR Part 820, ISO-13485, regulatory submissions to the FDA and other regulatory agencies.  Ideal candidate will have a degree in a discipline related to regulatory affairs with 5 years experience in a regulatory environment.

 

Must have experience applying regulatory requirements to a corporate and multi-site company with understanding of the medical device industry directives and the ability to work with FDA and international standards.  You will also support validation efforts of the company data-base for quality systems MQ-1, review complaint files for closure and ensure investigations conclusions are clearly documented as part of the record.  CAPA compliance with FDA guidelines experience is also a nice to have.  

 

LOCAL candidates only to the Tucson, AZ location, and must be authorized to work in the U.S. without sponsorship.



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