Compliance Engineer

As a Product Compliance Engineer, you will partner with global product developers and certification partners to manage regulatory compliance and product certification throughout the product lifecycle, including medical device regulatory pathways. Your focus will be on ensuring market access requirements are met, risk mitigation solutions are incorporated, and project schedules and regulatory timelines are achieved.

• Support the execution of certification activities and risk analysis for multiple new product development projects, including FDA‑regulated medical devices and products subject to EU MDR 2017/745.
• Assist in preparing regulatory filings including FDA 510(k) submissions and Technical Files/Design Dossiers, and maintain Design History Files (DHF) in compliance with 21 CFR Part 820 Design Controls and ISO 13485 requirements.
• Support the establishment of project needs and deliverables for product development teams and third‑party regulatory partners, including Notified Bodies and FDA‑accredited testing laboratories.
• Execute risk management activities in accordance with ISO 14971, including hazard identification, risk estimation, risk evaluation, and residual risk documentation across the product lifecycle.
• Support usability engineering processes per IEC 62366‑1, including participation in formative and summative evaluation planning for medical device products intended for home healthcare environments.
• Evaluate project risk during development and support contingency planning to overcome obstacles, including regulatory strategy adjustments driven by classification questions or design changes.
• Participate in weekly reviews for all assigned projects, presenting status and associated project risks including certification timelines and Notified Body or FDA feedback cycles.
• Ensure that all activities related to product certification commence and execute as planned and on schedule, with attention to FDA review timelines and CE marking milestones under EU MDR.
• Provide subject‑matter expert support to product development teams, offering counsel on medical device‑specific requirements including biocompatibility (ISO 10993 series), software lifecycle (IEC 62304), and home healthcare electrical safety (IEC 60601‑1‑11).
• Contribute to intradepartmental continuous improvement and special projects, including post‑market surveillance and complaint handling processes under 21 CFR Part 803 and EU MDR.

• Bachelor’s degree in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Systems Engineering, Materials Engineering, Computer Science, or a related technical discipline; RAC certification a plus.
• Relevant discipline context:
  Biomedical/Bioengineering backgrounds – ISO 10993 biocompatibility and clinical evaluation;
  Systems Engineering – ISO 14971 risk management and design controls;
  Chemical/Materials Engineering – material selection, substance compliance (REACH, RoHS), and biocompatibility testing;
  Computer Science/Software Engineering – IEC 62304 software lifecycle and embedded systems compliance.
• Minimum 2–4 years of compliance or design‑related experience with consumer, commercial, or medical electromechanical products.
• Working knowledge of medical device regulatory standards including:
  • IEC 60601‑1 and applicable collateral/particular standards (esp. IEC 60601‑1‑2 for EMC, IEC 60601‑1‑6 for usability, IEC 60601‑1‑11 for home healthcare environments)
  • ISO 14971 – Risk Management for Medical Devices
  • ISO 13485 – Quality Management Systems
  • IEC 62366‑1 – Usability Engineering
  • IEC 62304 – Medical Device Software Lifecycle (where applicable)
  • ISO 10993 series – Biocompatibility Evaluation
  • 21 CFR Part 820 – FDA Quality System Regulation
  • EU MDR 2017/745 – classification rules, Technical Documentation, and UDI obligations
  • FDA 510(k) submission processes
  • Familiarity with international medical device regulations for key markets (Health Canada, TGA Australia, ANVISA Brazil) preferred.
• Experience with DFMEA and medical‑grade risk management documentation (hazard analysis, risk control verification, residual risk justification).
• Exposure to or experience interfacing with FDA, Notified…