Overview

The Compliance Process Architect - Healthcare Technology SDLC interprets healthcare regulations (IEC 62304, ISO 14971, ISO 13485, 21 CFR 820/11) into actionable SDLC policies, SOPs, WIs, and templates. This role designs, optimizes, and governs software development processes for compliant, high-quality healthcare solutions. Collaborates with engineering and compliance teams to ensure efficiency, regulatory alignment, and continuous SDLC improvement.

Responsibilities

• Interpret healthcare regulations and standards into concrete SDLC policies, SOPs, WIs, and templates.
• Design and optimize software development processes for regulatory compliance and efficiency.
• Govern SDLC processes across engineering and compliance teams.
• Develop templates and tools to streamline compliant software delivery.
• Conduct process audits and gap analyses against standards like IEC 62304 and ISO 13485.
• Collaborate with stakeholders to align processes with business and regulatory needs.
• Drive continuous improvement initiatives in the SDLC framework.
• Provide training and guidance on compliance processes to development teams.

Qualifications

• 8+ years in healthcare software compliance, SDLC process design, or quality management.
• Deep expertise in IEC 62304, ISO 14971, ISO 13485, 21 CFR 820/11 regulations.
• Proven experience architecting SDLC policies, SOPs, and templates.
• Strong knowledge of agile, waterfall, and hybrid software development methodologies.
• Excellent collaboration skills with engineering, QA, and regulatory teams.
• Bachelor's degree in Computer Science, Engineering, or related field; advanced certifications preferred.

Benefits

• Competitive salary and performance bonuses.
• Comprehensive health, dental, and vision insurance.
• 401(k) matching and retirement savings plan.
• Flexible remote/hybrid work options.
• Professional development stipend and certification reimbursement.