Regulatory Expert in Quality Management
We are seeking an experienced Regulatory Specialist to lead the development and implementation of quality management systems.
Key Responsibilities:
* Design and validate automated regulatory processes for medical devices.
* Ensure compliance with applicable legislation and standards throughout the automation lifecycle.
* Collaborate with software development teams to align functional requirements with regulatory expectations.
* Review AI/ML models and automation tools from a regulatory perspective.
* Monitor evolving regulatory trends and contribute to internal best practices.
Requirements:
* Master's degree in Life Sciences, Biomedical Engineering, or related field.
* Training in ISO 13485, ISO 14971, and IEC 62304.
* 4+ years of experience in regulatory affairs or quality of medical devices.
* Up-to-date knowledge of medical device regulations and standards.
Benefits:
* Competitive annual base salary.
* Performance-based bonus and flexible work arrangements.
* Professional development and certification support.
* Impactful projects for the healthcare sector.