TEC Partners is pleased to have partnered with a pioneering medical device company who is set to pave the way for AI-based automated analysis software to overcome a global crisis affecting millions of lives.
Quality and Regulatory Specialist
As the Quality and Regulatory Specialist, you will play a pivotal role in my client's mission to deliver groundbreaking solutions in global diagnostics. Your key responsibilities will include document control and the ability to implement robust document control processes while working closely with the Head of Quality and Regulatory Affairs establish the QMS aligned with ISO 13485 requirements, driving continuous improvement and operation excellence.
The successful candidate will also compile technical files with comprehensive documentation to support regulatory submission and product certification while conducting risk management activities in accordance with ISO 14971, identifying potential hazards, assessing risks and implementing effective mitigation strategies.
Quality and Regulatory Specialist 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 comprehensive technical files for CE marking
- Collaborate with stakeholders to establish a QMS
Quality and Regulatory Specialist Requirements:
- Bachelor's degree in a relevant field (e.g., Engineering, Life Sciences, Regulatory Affairs)
- 2 years' experience in quality and regulatory affairs within the medical device industry, preferably with exposure to software (IEC 62304) and Software as a Medical Device (SaMD)
- Strong understanding of ISO 13485, ISO 14971, and other relevant regulatory standards
- Excellent communication skills with the ability to collaborate effectively across multidisciplinary teams
- Detail-oriented mindset with a commitment to maintaining the highest standards of quality and compliance
- Experience with CE marking processes and regulatory submissions is highly desirable
This is an exciting opportunity to be part of 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 driven to help you develop your career with a clear pathway set to develop up to a managerial level.
If you're interested, please apply with an up to date CV as this role will not be available for long.
