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.

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