Regulatory Engineer

Pay range

Base pay range: $90,000.00/yr - $/yr

Direct message the job poster from Highlander Consultants

The Regulatory Affairs Engineer will support new product development and lifecycle management activities to ensure medical devices comply with global regulatory and quality system requirements. This role works cross‑functionally with R&D, Quality, and Manufacturing to develop submissions, maintain Design History Files (DHF), and support audits and inspections.

• Partner with R&D and Engineering to ensure design controls, risk management, and verification/validation activities are planned and executed in accordance with 21 CFR 820.30 and ISO 13485.
• Own or support creation, organization, and maintenance of Design History Files (DHF) for new and existing devices, ensuring complete, accurate, and audit‑ready documentation of the design and development process.
• Review and approve engineering design inputs/outputs, test protocols, reports, and design changes for regulatory and DHF compliance.
• Prepare and support regulatory submissions (e.g., 510(k), PMA supplements, technical files/design dossiers) for new products and product changes in collaboration with cross‑functional teams.
• Interpret and apply applicable U.S. (FDA) and international (e.g., EU MDR) medical device regulations and standards to product development and sustaining engineering activities.
• Participate in risk management activities (e.g., FMEA) to ensure alignment with ISO 14971 and proper linkage into the DHF and related technical documentation.
• Support internal and external audits and regulatory inspections, including DHF reviews and responses to observations and findings.
• Monitor changes in global regulations and standards, assess impact on existing products and DHFs, and drive implementation of required updates.
• Review and approve labeling, IFUs, and promotional materials for regulatory compliance and consistency with cleared/approved indications.
• Contribute to continuous improvement of the Quality Management System (QMS), procedures, and templates related to design controls, DHF management, and regulatory affairs.

• Bachelor’s degree in Engineering (Biomedical, Mechanical, Electrical, or related) or a closely related technical discipline.
• Demonstrated experience in regulatory affairs, quality engineering, or design engineering within the medical device industry.
• Working knowledge of FDA medical device regulations (21 CFR Part 820, including design controls) and related guidance; familiarity with EU MDR and other global requirements preferred.
• Hands‑on experience with DHF creation, maintenance, and/or auditing, including design inputs/outputs, verification/validation, design reviews, and design change control.
• Understanding of ISO 13485 quality management system requirements and their application to product development and sustaining engineering.
• Strong documentation, organization, and technical writing skills with attention to detail in regulated environments.
• Ability to collaborate effectively with cross‑functional teams (R&D, Quality, Manufacturing, Clinical, Marketing) and manage multiple projects and deadlines.

• Master’s degree in Engineering or Regulatory-related discipline.
• RAC certification or equivalent regulatory credential.
• Experience supporting 510(k), PMA, or international submissions for Class II or III medical devices.
• Prior involvement in regulatory inspections, notified body audits, or MDSAP audits related to design controls and DHF

Mid‑Senior level

Full‑time

Quality Assurance and Engineering

Medical Equipment Manufacturing and Engineering Services

• Medical insurance
• Vision insurance
• 401(k)

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