Regulatory Affairs And Quality Specialist

Summary

Join Intelerad as a Regulatory Affairs & Quality Specialist and play a crucial role in maintaining and improving certifications like ISO 13485, MDSAP, and CE mark. You will ensure compliance with relevant standards and regulations, collaborating with the Regulatory Affairs and Quality Manager to integrate regulatory requirements into processes. This role involves providing guidance, support, and training to the organization. Responsibilities include managing CAPAs, maintaining QMS documentation, participating in adverse events and recalls, and overseeing audits. The ideal candidate possesses 3+ years of experience in quality management systems, a bachelor's degree, and knowledge of relevant ISO standards. The position offers the opportunity to contribute to a growing healthcare solutions company.

Requirements

• 3+ years of experience in quality management systems
• Bachelor’s degree in business, quality management, or related field (or equivalent)
• Knowledge of ISO 13485, MDSAP, and EMDR requirements
• Proficiency in MS Office, Google Suite, and Visio (or similar workflow tools)
• Experience in the IT / software (SaaS) and/or medical device field (SaMD / SiMD)

Responsibilities

• 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 by Intelerad
• Align cross-functional processes and update SOPs
• Collaborate on supplier processes and RC board management
• Manage EUDAMED renewals and quality plans

Preferred Qualifications

• Working knowledge of common security standards such as SOC 2 and ISO 27001
• Process mapping and creation
• Autonomy and self-motivation
• Strong collaboration skills
• Problem-solving abilities
• Continuous learning mindset
• Effective communication skills – English fluency