QA Regulatory and Safety Manager
MaineHealth•Scarborough, ME
About The Position
The QA Regulatory and Safety Manager coordinates and provides guidance for NorDx’s Quality Program and manages regulatory affairs and safety activities. The role interacts with federal, state, and professional regulatory agencies as required. The position may require work at other sites or locations as needed.
Requirements
- Bachelor’s degree in Medical Technology or an equivalent science is required.
- Current certification as a technologist or technician by a recognized professional organization, such as ASCP, BOR, or NCA, is required.
- Five years of progressive clinical laboratory experience is required.
Nice To Haves
- Master’s degree in business or healthcare.
- Certification as a specialist, such as SBB, SH, SM, or SI, or as a clinical laboratory leader.
- Experience in safety, quality assurance, and regulatory affairs.
- Basic computer skills.
Responsibilities
- Coordinate and provide guidance for NorDx’s Quality Program.
- Manage regulatory affairs and safety activities.
- Interact with federal, state, and professional regulatory agencies as required.
- Work at other sites or locations as needed.
Benefits
- Paid parental leave
- Flexible work options
- Student loan assistance
- Professional development opportunities
- Well-being resources
- Comprehensive benefits
- Recognition programs
- Career growth opportunities
- Shift differentials or other incentives, where applicable
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What This Job Offers
Job Type
Full-time
Career Level
Manager
