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Quality and Regulatory Manager

This job is no longer available

Employer
Doherty Top Talent
Posted
Friday, December 21, 2012
Closes
Sunday, January 20, 2013
Location
North Metro
Job Type
Employment Status
Salary
DOE

Further information

Top Career Solutions has teamed with a leading Medical Device manufacturer in the North Metro to hire a Regulatory and Quality Manager. This person will be in charge of overseeing quality, conducting audits, and oversee all regulatory activities. This is a full time, direct hire opportunity with standard Monday through Friday hours.

Job Duties:

·         Implement quality control procedures on all incoming product

·         Quality Assurance inspection, and maintaining proper documentation

·         Manage all regulatory activities and regulatory submissions

·         Coordinate Quality and Regulatory audits at all facilities

·         Follow regulatory submissions to FDA 510(k), IDE’s, and PMA

·         Follow ISO 13485 quality systems

 

Requirements:

·         5+ years in Medical Device company quality control department

·         Strong background in FDA and regulatory submisisons is required

·         Experience in an ISO 13485 environment required

·         Experience leading quality and regulatory audits

·         International background in MDD, Canadian, or Japanese requirements is preferred

·         Bachelor’s Degree in technical discipline, including Engineering or Sciences 

Doherty Top Talent

Doherty Top Talent is a Minnesota-based, full-service employment agency, offering temporary staffing, temp-to-hire, contract and direct-hire placement.