Sr Clinical Research & Regulatory Quality Lead (EU MDR)

BIOTRONIK SE & Co.KG; Tustin (CA); On-site; USD 150,000 - 220,000; Full time

Benefits offered by this job

Health insurance

Retirement plans

Paid time off

Job summary

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

Qualifications

• Minimum 10+ years of progressive experience in Quality Assurance, Quality Engineering, or Systems Engineering in cardiac medical devices.
• Experience implementing a QMS and SOPs and supporting ISO 13485 certification.
• Experience with Design Controls, Risk Management, IQ/OQ/PQ, CAPA, NCRs, GMP, and supplier quality.
• Experience interacting with Notified Bodies, FDA, and other regulatory authorities.

Responsibilities

• Lead the Quality Management System development, maintenance, and improvement.
• Prepare for ISO 13485 certification and EU MDR compliance.
• Oversee audits with internal, supplier, and regulatory bodies and ensure corrective actions.
• Provide quality engineering leadership across product development, verification, and validation.
• Manage supplier quality, CAPA, and continuous improvement programs.

Skills

Quality Assurance

Quality Engineering

Regulatory Compliance

Audit Readiness

CAPA

Supplier Quality

Design Controls

Risk Management

QMS

FDA Compliance

Education

Bachelor's degree in health, life sciences, engineering

Advanced degree preferred

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