Job Overview
Senior Quality Assurance and Regulatory Affairs Specialist
This senior quality assurance and regulatory affairs specialist plays a pivotal role in ensuring the quality management system adheres to regulatory standards for a leading healthcare solutions company. The ideal candidate will possess a strong technical background, experience in ISO 13485 and MDR-related projects.
Key Responsibilities:
* Collaborate with various teams to drive regulatory strategies for product lifecycle submissions, ensuring seamless integration with existing processes.
* Maintain compliance for medical devices by staying up-to-date with relevant regulations and industry developments.
* Oversee quality management activities, fostering an environment of continuous improvement.
Requirements:
* A bachelor's degree in a relevant field, such as engineering or life sciences.
* Proven experience in ISO 13485 and MDR-related projects, with a focus on quality management systems.