[Remote] Compliance Process Architect - Healthcare Technology SDLC

Note: The job is a remote job and is open to candidates in USA. Oracle is at the intersection of healthcare and IT, delivering pioneering products and services that enhance patient care. The Compliance Process Architect will be responsible for interpreting healthcare software regulations into concrete SDLC policies and optimizing software development processes to ensure compliance and efficiency.

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
• Collaborating with cross-functional teams to implement processes
• Support continuous education to ensure that processes are consistently followed and optimized
• Monitoring and analyzing 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

Skills

• 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

Benefits

• Medical, dental, and vision insurance, including expert medical opinion
• Short term disability and long term disability
• Life insurance and AD&D
• Supplemental life insurance (Employee/Spouse/Child)
• Health care and dependent care Flexible Spending Accounts
• Pre-tax commuter and parking benefits
• 401(k) Savings and Investment Plan with company match
• Paid time off: Flexible Vacation is provided to all eligible employees assigned to a salaried (non-overtime eligible) position. Accrued Vacation is provided to all other employees eligible for vacation benefits. For employees working at least 35 hours per week, the vacation accrual rate is 13 days annually for the first three years of employment and 18 days annually for subsequent years of employment. Vacation accrual is prorated for employees working between 20 and 34 hours per week. Employees working fewer than 20 hours per week are not eligible for vacation.
• 11 paid holidays
• Paid sick leave: 72 hours of paid sick leave upon date of hire. Refreshes each calendar year. Unused balance will carry over each year up to a maximum cap of 112 hours.
• Paid parental leave
• Adoption assistance
• Employee Stock Purchase Plan
• Financial planning and group legal
• Voluntary benefits including auto, homeowner and pet insurance

Company Overview