Medical Device Quality, Compliance & Regulatory Consultant

We are seeking an experienced Medical Device Quality, Compliance & Regulatory Consultant to support regulatory strategy, quality system compliance, and audit readiness activities for medical device products.

This consultant will ensure alignment with FDA and international regulatory requirements, support quality system improvements, and guide cross-functional teams through compliance initiatives.

The ideal candidate has strong experience with FDA regulations, ISO standards, risk management, and regulatory submissions within a medical device environment.

Key Responsibilities

• Provide regulatory strategy and compliance guidance for medical device products

• Ensure compliance with FDA 21 CFR Part 820 (QSR) and applicable global regulations

• Support implementation and maintenance of ISO 13485-compliant Quality Management Systems (QMS)

• Lead or support internal and external audits (FDA, notified bodies, supplier audits)

• Review and strengthen design control processes and documentation

• Support risk management activities in accordance with ISO 14971

• Guide CAPA investigations and quality system remediation efforts

• Support preparation and submission of regulatory filings (e.g., 510(k), PMA, Technical Files, CE Marking documentation)

• Provide regulatory impact assessments for product or process changes

• Partner cross-functionally with Engineering, Manufacturing, Clinical, and Quality teams

Required Qualifications

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

• 5+ years of experience in medical device regulatory affairs and/or quality systems

• Strong knowledge of:

  • FDA 21 CFR Part 820 (QSR)

  • ISO 13485

  • ISO 14971 Risk Management

  • EU MDR (if global scope)

• Experience supporting audits and regulatory inspections

• Experience with CAPA, complaint handling, and post-market surveillance

• Strong documentation and technical writing skills

• Ability to work independently in a consultant capacity

Preferred Qualifications

• Experience with Class II or Class III devices

• Experience preparing or supporting 510(k) or PMA submissions

• Experience with EU MDR Technical Documentation and CE marking

• Experience in medical imaging, diagnostics, or software as a medical device (SaMD)

• Prior consulting experience

Key Competencies

• Strong analytical and problem-solving skills

• Ability to translate regulatory requirements into practical implementation

• Excellent cross-functional collaboration and communication skills

• Detail-oriented with strong documentation discipline