Regulatory Affairs & Quality Specialist

Company Description

At Intelerad, we believe the path to answers in healthcare should be clear-whether you are waiting for a diagnosis or trying to expedite one. Our medical imaging solutions streamline the flow of information, simplifying complex processes, maximizing efficiencies, and shining a light on the unknown. We empower physicians to get patients the answers they need faster and improve outcomes for everyone. With more accessible imaging, we are getting patients out of the dark.

Headquartered in Raleigh, NC and Montreal, Intelerad has nearly 800 employees located in offices across four countries. The company empowers nearly 2,000 healthcare organizations around the world with the speed, scalability, and simplicity needed to increase business performance while, most importantly, improving patient outcomes. Intelerad’s modern enterprise solutions have been acknowledged by a Best in KLAS recognition, ranking #1 for PACS Asia/Oceania in the 2021 Best in KLAS: Global Software (Non-US) report.

Job Description

Purpose

The Regulatory Affairs & Quality Specialist plays a crucial role within the Regulatory Affairs department. This position is responsible for maintaining and improving certifications such as ISO 13485, MDSAP, and CE mark, as well as ensuring compliance with other relevant standards and regulations. The Specialist collaborates with the Regulatory Affairs and Quality Manager to integrate regulatory requirements into processes and procedures, while continuously enhancing the management system. This role also involves providing guidance, support, and training to the organization.

Responsibilities & Duties

• Manage Corrective and Preventative Actions (CAPAs): issue, assign, verify implementation, and ensure effectiveness within set timeframes
• Maintain QMS documentation and ensure proper retention of documents and records
• Participate in activities related to adverse events and recalls, including reporting, notification, and follow-ups
• Supervise and coordinate external QMS audits
• Conduct and/or coordinate internal QMS audits to ensure compliance with legal, regulatory, and ISO standards
• Provide advice and take action in response to audit findings and recommendations regarding information security
• Coordinate third-party audits to assess the adequacy of controls in place to protect the organization’s information
• Oversee and participate in the creation of QMS training materials and provide training as required; develop RAQ education programs and training sessions.
• Participate in Quality meetings, set new metrics, and ensure existing metrics are gathered, analyzed, and acted upon; collaborate with process owners to create, update, and review QMS documents
• Analyze and identify solutions to improve QMS efficiency; coordinate and participate in internal process improvement projects
• Work on special projects related to the organization’s goals, including reports, statistics, and research
• Collaborate with Privacy and Quality Managers to integrate new regulatory requirements into current processes
• Participate in other projects as deemed necessary
• Align cross-functional processes and update SOPs
• Collaborate on supplier processes and RC board management
• Manage EUDAMED renewals and quality plans.

Qualifications

Required Qualifications

• 3+ years of experience in quality management systems
• Knowledge of ISO 13485, MDSAP, and EMDR requirements
• Proficiency in MS Office, Google Suite, and Visio (or similar workflow tools)
• Experience in the IT and/or medical device field

Communication & Cognitive Abilities

• Process mapping and creation
• Autonomy and self-motivation
• Strong collaboration skills
…