Operations Regulatory Specialist II
CareSource
Process Compliance Manager
Prentke Romich GmbH
full-time
Posted on:
Location Type: Hybrid
Location: Wooster • Ohio • 🇺🇸 United States
Visit company websiteSalary
💰 $69,500 - $86,500 per year
Job Level
Junior
Tech Stack
ERP
About the role
- Maintains an efficient quality management system in accordance to the QSMR
- Develops monthly reports (CAPA, OFI, and OB) for Leadership Team
- Serves as main audit facilitator of FDA, ISO and ACHC external audits and assessments
- Provides support to product compliance, engineering and product development personnel
- Serves as main quality management system regulation (QMSR) software contact for implementation, support, training, and improvement activities
- Maintains external contacts in areas relating to process compliance
Requirements
- Bachelor’s Degree in a Quality or Compliance related field
- At least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices
- Knowledge of quality management systems, manufacturing planning, inventory control, and production processes
- Knowledge of ISO13485, FDA, ACHC, and European Medical Device Regulation (EUMDR) requirements
- Knowledge of different computer software: Windows, Microsoft Word, Excel, PowerPoint, document control, and enterprise resource planning (ERP)
Benefits
- Health insurance
- Flexible work arrangements
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
quality management systemsregulatory affairsCAPAOFIOBmanufacturing planninginventory controlproduction processesISO13485European Medical Device Regulation
Certifications
Bachelor’s Degree in Quality or Compliance related field
