Job Description

The Regulatory Affairs & Quality Manager plays a crucial role within the Regulatory Affairs department. This position is responsible for maintaining and improving certifications such as ISO 13485, as well as other relevant standards and regulations. The manager will oversee the Quality Management System (QMS), ensuring compliance and providing guidance, support, and training to the organization. Additionally, the manager will report to senior management on the status of ISO systems and certifications.

Key Responsibilities & Duties

• 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

Qualifications

• 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
• Experience owning deliverables, project management, and/or team leadership experience nice to have

Note: This job description is not intended to be all-inclusive. Employee may perform other related duties as requested to meet the ongoing needs of the organization.

Additional Information

All your information will be kept confidential according to EEO guidelines.

All applicants meeting minimum qualifications will be required to complete a 30 minute online assessment as part of your application.

#LI-REMOTE

Intelerad is committed to the principles of equal employment. We are committed to complying with all federal, state and local laws providing equal employment opportunities and all other employment laws and regulations. Applicants, employees and former employees are protected from employment discrimination based on race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), national origin, age , disability and genetic information (including family medical history). Intelerad is dedicated to the fulfillment of this policy regarding all aspects of employment, including but not limited to recruiting, hiring, placement, transfer, training, promotion, rates of pay, and other compensation, termination, and all other terms, conditions, and privileges of employment.

Intelerad is committed to ensuring equal employment opportunity for qualified individuals with disabilities. Intelerad uses the Americans with Disabilities Act (“ADA”)as a standard for global recruiting and hiring purposes. This prohibits discrimination against qualified individuals with disabilities. The ADA defines “disability” as a physical or mental impairment that substantially limits one or more of the major life activities of an individual, a record of such impairment, or being regarded as having such an impairment