Regulatory Engineer

Description

• Analyze historical Request for Change (RfS) and design change data to develop and maintain regulatory compliance checklists and criteria for software medical device documentation.​
• Develop, document, and execute remediation plans and associated Regulatory Affairs (RA) deliverables, such as updated DHF/technical files, risk management, usability, and labeling documentation.​
• Liaise with global regulatory agencies and notified bodies for submissions, clarifications, and product registrations as needed.​
• Work cross-functionally with product development, engineering, quality, and clinical teams to embed compliance considerations into all processes.​
• Support and lead internal audits, reviews, and preparations for external audits by notified bodies and competent authorities.
• Monitor ongoing global regulatory updates and proactively update internal processes and product files.​
• Perform systematic gap assessments on change records and documentation to identify compliance risks, deficiencies, and areas for improvement per current regional and international requirements.​
• Lead preparation of Compliance Data Reports (CDRs) and Test Report Forms (TRFs) to demonstrate compliance with IEC 62304, IEC 82304-1, IEC 62366-1, ISO 15223-1, ISO 20417, eIFU Regulation (EU-2021/2226), EU MDR [2017/745], UKCA, Canadian (SOR/98-282), and Australian (TGR) medical device regulations.​
• This role is ideal for professionals aiming to ensure best-in-class compliance and regulatory alignment for medical device software in an evolving regulatory environment.

Requirements

Educational Background

Bachelor’s degree Mechanical Engineering, Life Sciences, Computer Science, Regulatory Affairs, Biomedical Engineering

Advanced certifications (e.g., Regulatory Affairs Certification, ISO 13485 lead auditor, etc.) are a plus.​

• Hands-on experience preparing technical documentation, gap assessments, and compliance reports for the EU, US, and other key markets.
• Familiarity with electronic QMS and regulatory document management platforms is advantageous.
• Detailed understanding of medical device development lifecycles, quality systems, and regulatory science for medical software.​
• Strong organizational, documentation, and cross-functional communication skills.
• Experience in change management, risk assessment, and nonconformance remediation in a regulated environment.​
• Excellent written and verbal communication skills for preparing high-quality submissions and interacting with global teams or regulators.
• Strong analytical abilities for reviewing design changes, identifying compliance gaps, and formulating action plans.​
• Minimum 3–5 years of professional experience in regulatory affairs, quality assurance, or compliance for medical devices; at least 1–2 years focused on Software as a Medical Device (SaMD) or medical device software.​
• Practical knowledge of the cited standards (IEC 62304, IEC 82304-1, IEC 62366-1, ISO 15223-1, ISO 20417), and global device regulations (EU-MDR, UKCA, Canadian, and Australian frameworks).​

Benefits

Training + Development

Interview process

Visa Sponsorship

Security clearance