Sr. Regulatory Affairs Specialist

We are seeking a detail-oriented Quality & Regulatory Specialist to support compliance, quality management, and regulatory activities. This role ensures adherence to international regulations and standards, supports product registrations, and maintains the company’s Quality Management System (QMS). This position requires strong knowledge of medical device regulations (e.g., FDA, EU MDR, ISO 13485) and excellent cross‑functional collaboration.

• Regulatory Affairs
• Lead preparation, submission, and maintenance of global regulatory filings (FDA 510(k)/PMA, EU MDR Health Canada and other international registrations).
• Serve as primary contact with regulatory authorities, notified bodies, and certification agencies.
• Interpret evolving regulatory requirements and communicate strategic implications to leadership.
• Provide regulatory input on new product development, product changes, labeling, and marketing materials.
• Monitor regulatory changes and advise internal teams on impact to product development and market access.
• Quality Management System (QMS)
• Maintain and improve the QMS in compliance with ISO 13485, 21 CFR Part 820, and applicable standards.
• Support internal and external audits, inspections, and corrective actions.
• Ensure document control, training, and change management processes are properly implemented.
• Product Lifecycle Support
• Partner with R&D, manufacturing, and clinical teams to ensure design control, risk management, and post‑market surveillance compliance.
• Review and approve quality/regulatory aspects of labeling, promotional materials, and product changes.
• Support vigilance reporting, complaint handling, and CAPA activities.
• Cross‑Functional Collaboration
• Provide regulatory and quality guidance during new product development.
• Liaise with regulatory authorities, notified bodies, and certification agencies.
• Train employees on regulatory and quality compliance topics.
• Perform other duties as assigned by manager or supervisor

• Bachelor’s degree in engineering, life sciences, regulatory affairs, or related field or equivalent work experience in those areas.
• 5-8 years of experience in quality and/or regulatory affairs in the medical device industry.
• Strong knowledge of ISO 13485, ISO 14971, 21 CFR Part 11/820, EU MDR 2017/745.
• Experience with regulatory submissions (FDA, EU, or other international markets).
• Excellent analytical, organizational, and communication skills.

• Medical device industry experience
• Medical Device regulation requirements knowledge, as applicable to responsibilities
• Regulatory Affairs / Quality Assurance Certification (e.g., RAC, CQE, CQA) is a plus.