Quality & Regulatory (QA/RA) Manager
On-site · Wakeman, Ohio, United States
Job Summary
Quality & Regulatory (QA/RA) Manager provides leadership, direction and hands-on involvement with Regulatory Affairs and Quality Management Systems for Medical Device Manufacturing. Responsible for maintaining compliance with domestic quality system requirements, overseeing Plant Quality, Microbiology/Sterilization, and Document Control, and supporting product staff with quality/regulatory input. Leads development and maintenance of quality and regulatory systems, conducts internal and external audits, plans and implements regulatory and quality activities, and supports UDI data management (including GUDID/EUDAMED). Manages installation, operational and performance qualifications (IQ/OQ/PQ) for equipment and the clean room, coordinates data entry for UDI updates, and prepares quality documentation and management reviews. Requires strong collaboration, budgeting, and continuous improvement mindset, with ability to interact with FDA/ISO auditors and supplier controls.
Required Qualifications
- BS or BA degree in life science or related field
- 5–7 years of experience in QA and Regulatory Affairs
- Knowledge and direct working experience with ISO and FDA GMPs regulations
- Advanced training and certifications related to quality assurance a plus
- Experience leading and developing a collaborative team
- Ability to work with Government officials and FDA/ISO auditors
- Excellent project management, interpersonal, verbal and written communication skills
- Ability to exercise authority, manage conflict, and influence others positively
- Ability to work with other groups outside QA/RA
- Ability to lead meetings and small groups
- Working knowledge of Microsoft Word, Excel, and Master Control or cloud-based quality systems
- Working knowledge of ERP & PLM systems
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