Design Controls & Risk Management Lead

Spark Life Solutions Inc is seeking a Design Controls & Risk Management Lead to serve as the technical lead responsible for driving design control and risk management remediation activities. This role ensures compliance with regulatory and quality standards while collaborating with cross-functional teams to integrate risk management processes across the Quality Management System.

Responsibilities:

• Lead Design History File (DHF) remediation and design control activities
• Provide Subject Matter Expertise (SME) in design controls and risk management aligned with ISO 13485 and ISO 14971
• Drive system-level risk management remediation, identifying gaps in risk integration and governance
• Oversee CAPA activities related to design control and risk management observations
• Ensure proper escalation of quality and regulatory issues identified during remediation
• Strengthen integration of risk outputs into QMS processes including:
• Management Review
• CAPA
• Change Control
• Ensure post-market surveillance signals feed back into risk files and benefit-risk assessments
• Collaborate cross-functionally to ensure risk management interfaces across design and quality systems are properly addressed
• Support remediation efforts in response to regulatory inspections or findings

Requirements:

• 8+ years of experience in medical device design controls and/or risk management
• Strong expertise in Design History File (DHF) remediation
• Deep knowledge of ISO 13485:2016, ISO 14971, and FDA QMSR requirements
• Experience leading regulatory remediation initiatives following audit or inspection findings
• Proven ability to lead cross-functional quality and risk management initiatives
• Strong understanding of medical device product lifecycle and quality systems
• Prior experience serving as ISO 14971 SME
• Experience with FDA inspection readiness or remediation programs
• Background working with global medical device regulatory frameworks