Principal Regulatory Engineer

Your role:

• Lead regulatory planning and strategy for global product registrations (including 510(k), CE Marking under MDD/EU MDR, Technical Files), and oversee worldwide product submissions and post-market surveillance.
• Advise on regulatory risk assessment, corrective actions, and compliance with global standards (such as ISO 13485, ISO 14971, 60601, 21 CFR parts 1000/1001), and participate in program meetings to ensure alignment with international requirements.
• Review and recommend changes to labeling, marketing communications, clinical protocols, design processes, and manufacturing procedures to maintain regulatory and quality compliance.
• Drive improvements in Quality System processes, document procedures for effective system maintenance, and play a key role in internal and external audits (including FDA, SFDA, KFDA, JPAL, and notified bodies).
• Serve as Regulatory Affairs representative for CT/AMI Systems, guiding risk management, defect and complaint review, and supporting regulatory aspects throughout the Development Life Cycle.

You're the right fit if:

• You’ve acquired 7+ years of experience with SaMD/SiMD in areas such as Regulatory Affairs, Quality Compliance, Product Development, etc. in Medical Devices Industry or equivalent. Experience authoring submissions (510k, EU Tech Files, etc.) required. Experience with sustaining and new product development is ideal.
• Your skills include knowledge and experience with regulatory compliance and engineering standards related to safety like radiation and emitting product standards, as well as other standards related to SaMD (60601, 21 CFR parts 1000 and 1001 for radiation emitting devices, and XR 25, 26, 28, and 29, ISO 13485 & 14971, etc.).
• You have a bachelor’s degree or higher in an engineering or scientific area preferred. RAPS RAC certified preferred.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
• You’re an excellent communicator (written and verbal) with a strong ability to work cross-functionally. You must be willing and able to travel up to 15% domestically and globally as needed.

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

This is an office-based role.