Compliance SME – Medical Device Software

Job Description: • Lead and support regulatory compliance initiatives for medical device software (SaMD). • Lead classification and regulatory pathway analysis for SaMD under FDA guidelines, including 510(k) submissions. • Facilitate early engagement with FDA through pre-submission meetings. • Implement and maintain QMS in accordance with ISO 13485:2016. • Oversee document control, change management, and supplier qualification processes. • Ensure integration of risk management into QMS activities. • Ensure software development processes align with IEC 62304 standards. • Manage software safety classification (Class B or higher). • Oversee development planning, requirements analysis, design, implementation, verification, validation, and release. • Apply ISO 14971 principles to identify, evaluate, and mitigate risks throughout the product lifecycle. • Collaborate with cross-functional teams to ensure risk controls are effectively implemented and documented. Requirements: • Bachelor's or Master’s degree in Engineering, Life Sciences, or related field. • 7+ years of experience in regulatory compliance for medical devices or SaMD. • Proven expertise in FDA regulations, ISO 13485, IEC 62304, and ISO 14971. • Strong understanding of software development and validation processes. • Excellent communication and documentation skills. • Preferred: Experience with international regulatory bodies (e.g., EU MDR, Health Canada). • Preferred: Certification in Regulatory Affairs or Quality Management. • Preferred: Familiarity with digital health technologies and AI/ML in medical devices. Benefits: • Opportunity to work on cutting-edge medical technologies. • Collaborative and inclusive work environment. • Competitive compensation and benefits. Apply tot his job