Job Summary:

The Design Controls Specialist is responsible for establishing, maintaining, and ensuring compliance of design control processes in accordance with regulatory requirements (FDA 21 CFR Part 820, ISO 13485, and applicable combination product guidelines). This role will own and manage Design History Files (DHF) and oversee product lifecycle management for transdermal drug delivery systems, ensuring traceability, risk management, and design integrity from concept through commercialization and post-market changes.

Job Responsibilities:

Design Control & Design History File (DHF) Management

• Lead the creation, organization, review, and maintenance of Design History Files (DHF) for transdermal patch products.
• Ensure DHFs demonstrate full compliance with:
  • FDA 21 CFR 820.30 (Design Controls)
  • ISO 13485 design and development requirements
  • Combination product regulations (21 CFR Part 4)
• Maintain complete design traceability from:
  • User needs → Design inputs → Outputs → Verification → Validation → Design transfer
• Perform routine audits and gap assessments of DHFs to ensure completeness and inspection readiness.
• Ensure proper version control and document integrity within electronic document management systems (e.g. Trackwise).

Design Lifecycle Management

• Support end-to-end product lifecycle management for transdermal patches:
  • Concept development
  • Feasibility and design planning
  • Verification & validation
  • Commercialization
  • Post-market lifecycle management
• Drive and manage design changes (ECR/ECN) ensuring proper documentation, impact assessments, and approvals.
• Collaborate with cross-functional teams to ensure lifecycle activities meet regulatory and quality expectations.

Risk Management & Compliance

• Facilitate and maintain risk management documentation (ISO 14971 aligned), including:
  • Risk analyses (FMEA, FTA)
  • Risk control measures
  • Risk-benefit justifications
• Ensure integration of risk management into design controls and lifecycle activities.
• Support internal and external audits, including FDA inspections and notified body audits.
• Act as subject matter expert on design control compliance for transdermal systems

Cross-Functional Collaboration

• Partner with:
  • R&D / Formulation Scientists
  • Engineering (process, packaging, and equipment)
  • Quality Assurance & Regulatory Affairs
  • Manufacturing and Operations
• Ensure alignment between product design, process design, and manufacturing transfer.
• Support Design Transfer activities ensuring readiness for commercial production.

Documentation & Systems

• Maintain and improve Quality Management System (QMS) procedures related to design controls.
• Develop templates, SOPs, and best practices for DHF and lifecycle documentation.
• Ensure all documentation supports labeling, stability, and performance requirements of transdermal patches.
• Support digital transformation of DHF and lifecycle records when applicable.

• All other duties as assigned.