Compliance Process Architect - Healthcare Technology SDLC

About the role

The Compliance Process Architect - Healthcare SDLC plays a crucial role within our Healthcare Compliance Team. They interpret and translate healthcare software regulations/standards (such as IEC 62304, ISO 14971, ISO 13485, 21 CFR 820/11, etc.) into concrete SDLC policies, SOPs, and WIs. This individual designs, optimizes, and governs software development processes to deliver high-quality, compliant, and effective healthcare technology solutions.

Responsibilities

• Interpret and translate healthcare software regulations/standards (IEC 62304, ISO 14971, ISO 13485, 21 CFR 820/11, etc. as applicable) into concrete SDLC policies, SOPs, and WIs.
• Author and own SDLC policy and harmonized SOP set; manage document lifecycle (draft, review, approval, periodic revalidation).
• Analyze, design, and optimize software development processes for delivery of SaMD products, ensuring efficiency and compliance with healthcare regulations.
• Establish and maintain standardized process documentation, including workflows, standard operating procedures (SOPs), and work instructions aligned with both agile and traditional SDLC methodologies.
• Ensure processes align with organizational objectives, customer expectations, and industry best practices.
• Guide the integration of regulatory and quality requirements into software development practices and documentation.
• Serve as a subject matter expert on healthcare software development processes, providing guidance and training as needed.
• Collaborate with cross-functional teams to implement processes.
• Support continuous education to ensure that processes are consistently followed and optimized.
• Monitor and analyze process performance data to identify areas for improvement and recommend corrective actions.
• Drive continuous improvement initiatives.
• Contribute to broad, cross-functional projects and initiatives.
• Support audits and regulatory reviews by maintaining up-to-date and accurate process documentation.
• Staying up to date with industry trends and emerging technologies to ensure processes remain effective and relevant.

Qualifications

• Bachelor's degree in Business, Management or related field, or equivalent, relevant work experience.
• 7+ years of experience with at least 3 years of regulatory health care technology related work experience within a SaMD environment.
• In-depth understanding of healthcare regulations and standards relevant to software (e.g. FDA 21 CFR Part 820, ISO 13485:2016, EU MDR).
• Proven experience in process development within a healthcare software development environment.
• Strong knowledge of software development processes and quality management systems.
• Exceptional verbal and written communication and facilitation skills.
• Ability to operate effectively in a dynamic, fast-paced, and regulated environment.