What are the responsibilities and job description for the Quality Systems and Regulatory Affairs Specialist position at Empyrean Medical Systems, Inc.?
- Assist in the development, implementation, and maintenance of the QMS to ensure compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable standards.
- Design, develop and maintain policies, procedures, work instructions, forms and other QMS documentation throughout the organization.
- Manage the document control system, ensuring timely updates and approvals of controlled documents.
- Prepare and maintain regulatory submissions and technical documentation for global markets, including the U.S. FDA, EU MDR, and other global medical device regulations.
- Assist with product classification, registration, and listing activities in compliance with regulatory requirements.
- Support external audits and inspections by regulatory authorities and notified bodies.
- Ensure compliance with labeling, promotional materials, and product claims in alignment with regulatory guidelines.
- Provide training to staff on QMS processes, regulatory requirements, and applicable standards.
- Monitor post-market surveillance activities and report adverse events or trends.
- Develop, implement and improve the quality management systems processes as the organization grows and the product line broadens.
- Assist the organizations personnel with risk management, corrective and preventive actions, document controls and customer complaint activities.
- Other various tasks and activities as assigned.
Qualifications
- Previous experience: (1 to 3 years) in the design and/or manufacturing of an approved (FDA Class II) medical device(s) and related accessories.
- Education: Minimum 2-year College degree. Preferred: Bachelor’s degree in a related STEM field.
- Quality Management Systems experience – ISO13485/ISO9001.
- Able to effectively interact across functional areas, with various levels of team leaders and personality types.
- Start up environment