Job Description

Job description



Job Summary


The DHF Specialist is responsible for managing and maintaining Design History Files (DHFs) in compliance with FDA 21 CFR Part 820, ISO 13485, and EU MDR requirements. With strong expertise in design controls, this role ensures complete, accurate, and audit-ready documentation throughout the medical device product lifecycle. The ideal candidate has solid experience in regulated medical device environments and collaborates effectively across cross-functional teams.


Key Responsibilities



  • Lead the development, compilation, and maintenance of DHFs for Class II medical devices.

  • Ensure full compliance of design control documentation, including Design Inputs, Outputs, Reviews, Verification & Validation, and Design Transfer.

  • Establish and maintain traceability across User Needs, Risk Management (ISO 14971), and Verification protocols.

  • Partner with R&D, Regulatory Affairs, Quality, and Manufacturing teams to ensure timely and compliant documentation.

  • Conduct regular DHF audits and gap assessments; drive corrective actions as needed.

  • Support regulatory submissions (e.g., 510(k), CE Marking) by preparing and reviewing DHF content.

  • Manage document control activities within QMS platforms (e.g., MasterControl, Greenlight Guru, Veeva Vault).

  • Contribute to process improvements in design control workflows and QMS procedures.

  • Provide training and guidance to engineering teams on DHF best practices and regulatory expectations.


Qualifications



  • Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Life Sciences, or related field.

  • 4–6 years of experience in the medical device industry, with direct involvement in design controls and DHF management.

  • In-depth knowledge of FDA 21 CFR Part 820, ISO 13485, EU MDR, and ISO 14971.

  • Proven experience with Class II devices (Class III a plus).

  • Proficiency in electronic QMS systems and document control practices.

  • Strong organizational, communication, and problem-solving skills.

  • Ability to work independently and manage multiple priorities in a fast-paced environment.



Preferred:



  • Experience supporting FDA or Notified Body audits.

  • Familiarity with usability engineering (IEC 62366) and software validation (IEC 62304).

  • Green Belt or training in Lean, Six Sigma, or CAPA systems.


Key Competencies



  • Regulatory Compliance

  • Technical Documentation

  • Cross-functional Collaboration

  • Attention to Detail

  • Project Coordination



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