Job Description: Compliance SME Medical Device Software
Department: Regulatory & Quality Assurance
Role Overview:
We are seeking a highly skilled and detail-oriented Compliance Subject Matter Expert (SME) to lead and support regulatory compliance initiatives for medical device software.
The ideal candidate will have deep expertise in global regulatory frameworks, quality management systems, and risk management practices applicable to software as a medical device (SaMD).
Key Responsibilities:
Regulatory Strategy & Engagement:
- 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 Masters 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 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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