Quality & Regulatory Specialist

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TEC Partners is pleased to have partnered with a pioneering medical device company that is set to pave the way for AI-based automated analysis software to address a global crisis affecting millions of lives.

Quality and Regulatory Specialist

As the Quality and Regulatory Specialist, you will play a pivotal role in our client's mission to deliver groundbreaking solutions in global diagnostics. Your key responsibilities will include document control, implementing robust document control processes, and working closely with the Head of Quality and Regulatory Affairs to establish the QMS aligned with ISO requirements, driving continuous improvement and operational excellence.

The successful candidate will also compile technical files with comprehensive documentation to support regulatory submissions and product certification, while conducting risk management activities in accordance with ISO standards, identifying potential hazards, assessing risks, and implementing effective mitigation strategies.

Key Responsibilities:

• Manage and organize quality and regulatory documentation
• Ensure timely and accurate filing per industry standards
• Maintain compliance with regulatory requirements
• Collaborate with teams for regulatory compliance training
• Implement robust document control processes
• Maintain compliance throughout the product lifecycle
• Assist with the development of technical files for CE marking
• Collaborate with stakeholders to establish a QMS

Requirements:

• Bachelor's degree in a relevant field (e.g., Engineering, Life Sciences, Regulatory Affairs)
• At least 2 years' experience in quality and regulatory affairs within the medical device industry, preferably with exposure to software (IEC standards) and Software as a Medical Device (SaMD)
• Strong understanding of ISO standards, IEC regulations, and other relevant regulatory standards
• Excellent communication skills and ability to collaborate effectively across multidisciplinary teams
• Detail-oriented with a commitment to maintaining high standards of quality and compliance
• Experience with CE marking processes and regulatory submissions is highly desirable

This is an exciting opportunity to join a dynamic and innovative company dedicated to making a meaningful impact on the lives of millions affected by diabetes. If you are driven by excellence, passionate about regulatory compliance, and eager to contribute to the future of healthcare, the Head of Quality and Regulatory Affairs is committed to helping you develop your career with a clear pathway to a managerial role.

If you're interested, please apply with an up-to-date CV, as this role will not be available for long.