Design & Regulatory SME – DHF Remediation

• *Job Title: Design & Regulatory SME – DHF Remediation (Multiple Disciplines) • *Location: Remote • *Duration:** 9+ Months • *Role Summary** We are seeking experienced Subject Matter Experts (SMEs) to support a • *Design History File (DHF) remediation program** within a regulated medical device environment. This role encompasses design quality, design controls, design transfer, regulatory affairs, and risk management, ensuring compliance with global standards and improving product lifecycle processes. • *Key Responsibilities • *Design Quality & Compliance • Assess and enhance design quality processes across the product lifecycle • Ensure compliance with design control requirements and quality systems (FDA, ISO 13485) • Support audit readiness and documentation reviews • *Design Control & DHF Remediation • Review and remediate design inputs, outputs, and verification/validation documentation • Ensure traceability across design elements (requirements to testing) • Strengthen design control processes within DHF • *Design Transfer • Support transfer of product designs into manufacturing environments • Ensure completeness and compliance of Device Master Records (DMR) • Identify and resolve design transfer gaps in collaboration with manufacturing teams • *Regulatory Affairs • Provide guidance on FDA and global regulatory requirements • Support regulatory strategy, submissions, and compliance reviews • Evaluate DHF documentation for regulatory alignment • *Risk Management • Perform and remediate risk assessments (FMEA, hazard analysis) • Ensure compliance with ISO 14971 • Integrate risk management activities into the product lifecycle • Support risk-based decision making • *Required Qualifications • Bachelor’s degree in Engineering, Life Sciences, or related field • Extensive experience in medical device or regulated industries • Strong knowledge of: • FDA regulations (21 CFR 820) • ISO 13485 and ISO 14971 • Hands-on experience with: • DHF remediation • Design controls and lifecycle documentation • Risk management (FMEA, hazard analysis) • Design transfer and DMR • *Core Skills & Competencies • Strong auditing, documentation, and analytical skills • Ability to manage cross-functional collaboration (Quality, Regulatory, Manufacturing, R&D) • Deep understanding of product development lifecycle • Excellent communication and stakeholder management skills • Detail-oriented with strong problem-solving capability • *Preferred Qualifications** • Experience supporting regulatory submissions • Prior involvement in large-scale remediation or compliance programs • Experience working in fast-paced, multi-disciplinary environments