Regulatory Affairs And Quality Manager

Summary

Join Intelerad as a Regulatory Affairs & Quality Manager and play a crucial role in maintaining and improving certifications like ISO 13485 and other relevant standards. You will oversee the Quality Management System (QMS), ensuring compliance and providing guidance. Responsibilities include interfacing with regulatory bodies, staying current with regulations, coordinating regulatory compliance for new products and markets, and presenting compliance information to management. You will also oversee QMS management, participate in adverse event handling, collaborate with other managers, conduct internal audits, and develop training materials. This role requires significant experience in medical device regulatory affairs and a relevant bachelor's degree. The position offers the opportunity to work remotely (#LI-REMOTE).

Requirements

• 3+ years of medical device regulatory experience required; SaMD a plus
• Bachelor's degree in business, quality management, or a related field (or equivalent)
• Knowledge of ISO 13485, ISO 9001, and/or ISO 27001 standards
• Proficiency in MS Office, Google Suite, and Visio (or similar workflow tools)
• Strong verbal and written communication skills in English
• Experience in the IT and/or medical device field
• Process mapping and creation
• Ability to work autonomously
• Strong collaboration skills
• Problem-solving abilities
• Continuous learning mindset

Responsibilities

• Interface with the FDA, Notified Bodies, Health Canada, and other international regulators
• Stay current with FDA and international medical device regulations
• Maintain up-to-date knowledge of ISO 27001 standards
• Coordinate regulatory compliance for new markets, products, design files, technical files, and 510(k) submissions
• Present regulatory and compliance information and statistics to management
• Oversee the management of QMS, including CAPAs, procedures, documentation, and records
• Participate in activities related to adverse events and recalls, including reporting, notification, and follow-ups
• Collaborate with the Privacy Compliance Manager to address information security or privacy incidents and propose improvement solutions
• Ensure company compliance with processes and training programs
• Conduct and/or coordinate internal audits to ensure compliance with legal, regulatory, and ISO standards
• Provide advice and take action in response to audit findings, making recommendations for information security improvements
• Coordinate third-party audits to assess the effectiveness of information protection controls
• Develop and deliver QMS training materials and provide training as needed
• Support and guide the Regulatory Compliance Specialist on improvement projects related to QMS, ISMS, and regulatory affairs
• Supervise and participate in internal process improvement projects, new process development, and regulatory strategy development
• Collaborate with Privacy and Quality Managers to integrate new regulatory requirements into existing processes
• Implement and support the electronic Quality Management System (eQMS)
• Establish an AdPromo review and approval process for the Regulatory Affairs & Quality business unit
• Work on projects for DICOM Grid and supervise and support Inteleshare and Intelescreen projects

Preferred Qualifications

Experience owning deliverables, project management, and/or team leadership experience

Benefits

#LI-REMOTE