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
