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
Apply Now
Apply Now
• *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
Apply Now
Apply Now