Senior Regulatory Affairs Associate Full Time

Job Summary

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

Essential Duties & Responsibilities

Regulatory Affairs

• Lead preparation, submission, and maintenance of global regulatory filings (FDA 510(k)/PMA, EU MDR, Health Canada, and international registrations).
• Serve as primary contact with regulatory authorities, notified bodies, and certification agencies.
• Monitor evolving regulatory requirements and communicating impacts to leadership.
• Provide regulatory guidance on new product development, product changes, labeling, and marketing materials.
• Advise internal teams on compliance impacts 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 proper document control, training, and change management processes.

Product Lifecycle Support

• Partner with R&D, manufacturing, and clinical teams to ensure compliance with design control, risk management, and post-market surveillance.
• Review and approve quality/regulatory aspects of labeling, promotional materials, and product changes.
• Support complaint handling, vigilance reporting, 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 compliance topics.
• Perform additional duties as assigned.

Experience & Education Requirements

• Bachelor’s degree in engineering, life sciences, regulatory affairs, or related field (or equivalent experience).
• Minimum 8-10+ years of experience in regulatory affairs within the medical device industry.
• Strong knowledge of ISO 13485, ISO 14971, 21 CFR 11/820, EU MDR 2017/745.
• Hands-on experience with regulatory submissions (FDA, EU, or international).
• Excellent analytical, organizational, and communication skills.
• Regulatory Affairs or Quality certifications (RAC, CQE, CQA) are a plus.