Compliance SME – Medical Device Software
4 days ago
• Lead classification and regulatory pathway analysis for SaMD under FDA guidelines, including 510(k) submissions.
• Facilitate early engagement with FDA through pre-submission meetings. Quality Management System (QMS):
• 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. Software Lifecycle Compliance:
• 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. Risk Management:
• 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. Required Qualifications:
• Bachelor's or Master's degree in Engineering, Life Sciences, or related field.
• years of experience in regulatory compliance for medical devices or SaMD.
• Proven expertise in FDA regulations, ISO 13485, IEC 62304, and ISO
• Strong understanding of software development and validation processes.
• Excellent communication and documentation skills. Preferred Qualifications:
• Experience with international regulatory bodies (e.g., EU MDR, Health Canada).
• Certification in Regulatory Affairs or Quality Management.
• Familiarity with digital health technologies and AI/ML in medical devices. What We Offer:
• Opportunity to work on cutting-edge medical technologies.
• Collaborative and inclusive work environment.
• Competitive compensation and benefits.
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