About this opportunity
BIOTRONIK SE & Co.KG lists this Sr Clinical Research & Regulatory Quality Lead (EU MDR) opportunity in tustin, California. Review the employer’s description below for duties, qualifications and application requirements.
Job description
BIOTRONIK is seeking a seasoned Director, Quality Assurance to lead and evolve the CRC EP Quality Management System. You will drive regulatory readiness, audits, and cross-functional quality engineering across cardiac ablation technologies.
Strong leadership and deep knowledge of ISO 13485, EU MDR, FDA guidance are required. The role requires collaboration with Regulatory Affairs, Engineering, Clinical, and suppliers to ensure product conformity, audit readiness, and continuous improvement while
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Worksite address
tustin, CA, 92681, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.