Meridian Bioscience Inc.

Compliance

• Responsible for supporting Meridian’s regulatory and quality processes
• Assist the regulatory department with product compliance throughout all stages of the product lifecycle
• Provide support and guidance to quality and regulatory activities, including Design Control activities
• Supports and helps draft sections of regulatory submissions for domestic, worldwide commercialization
• Drafts, evaluates, and reviews technical protocols and data in support of clinical trials
• Reviews software architecture, software requirements, traceability, verification and validation documentation
• Provides direct support associated with adverse events, medical device reportable events and product recall activities
• Supports cybersecurity compliance activities

Senior SW Compliance Specialist – Regulatory Affairs, Design Assurance

Manager

• Identify and establish ongoing relationships at Health System’s corporate headquarters
• Lead and assist the development and execution of strategies to identify new Health Systems
• Serve as a product expert, providing insights and guidance on emerging trends
• Facilitate the National or Regional rollout/launch of strategic Health System agreements
• Provide coaching and strategic guidance to local Meridian Account Executives
• Conduct Quarterly/Semi-annual Business Reviews with contracted Health Systems
• Manage and report quarterly contract performance and compliance to signed contracts/agreements

Senior SW Compliance Specialist – Regulatory Affairs, Design Assurance

Health Systems Manager