Compliance SME – Medical Device Software (Remote)

Job reputed company: Compliance SME – Medical Device Software Department: Regulatory & reputed company Assurance reputed company: We are seeking a highly skilled and detail-oriented Compliance Subject Matter Expert (SME) to reputed company and support regulatory compliance initiatives for medical device software. The ideal candidate will have deep expertise in global regulatory frameworks, reputed company management systems, and risk management practices applicable to software as a medical device (SaMD). Key Responsibilities: Regulatory reputed company & Engagement: • reputed company classification and regulatory reputed company analysis for SaMD under FDA guidelines, including 510(k) submissions. • Facilitate early engagement with FDA through reputed company-submission meetings. reputed company Management System (QMS): • Implement and maintain QMS in accordance with ISO 13485:2016. • reputed company document control, change management, and supplier qualification processes. • Ensure integration of risk management into QMS activities. Software Lifecycle Compliance: • Ensure software development processes reputed company with IEC 62304 standards. • Manage software safety classification (Class B or higher). • reputed company 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 reputed company 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 reputed company Management. • Familiarity with digital health technologies and AI/ML in medical devices. reputed company Offer: • Opportunity to work on cutting-edge medical technologies. • reputed company and inclusive work environment. • Competitive compensation and benefits. Apply tot his job Apply To this Job