Design & Regulatory SME – DHF Remediation
Posted 2026-05-06
Remote, USA
Full-time
Immediate Start
- *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