Principal Clinical Research Analyst - Class III Medical Devices; EU MDR Clinical Affairs Expert

Career Opportunities:
Principal Clinical Research Analyst - Class III Medical Devices (EU MDR Clinical Affairs Expert) 1 (62499)

Requisition
62499
-Posted
09/09/2026
- Posting Country (1) - Work Location (1)
- Administration and Office

- Unlimited

- Full-time

- Mid-Career

- BIOTRONIK

BIOTRONIK is one of the leading manufacturers of cardio and endovascular implants and catheters for cardiac rhythm management, electrophysiology and vascular intervention. As a globally active company headquartered in Berlin, Germany, we develop, produce and distribute high-quality medical products based on the latest technology and research. Our success is based on the competence and results-oriented cooperation of our employees.

California Research Center Electrophysiology, Inc (CRC EP, Inc.),a Biotronik business unit located in Tustin, CA, develops pulsed-field cardiac ablation (PFA) technologies. The team has recently completed the First-in-Human clinical trial which validated the company’s PFA technology for treatment of atrial fibrillation. The team is embarking on preparing the technology for regulatory approvals followed by commercial release in respective territories. We are continually looking for talented engineers, scientists, and professionals to share in our mission.

We are seeking a highly experienced Director, Quality Assurance to establish, lead, and continuously improve the CRC EP Quality Management System while providing strategic Quality Engineering leadership for breakthrough pulsed-field cardiac ablation technologies. The ideal candidate will bring at least 10 years of progressive experience in Quality Assurance, Quality Engineering, or Systems Engineering within the cardiac medical device industry, with deep expertise in ISO 13485, EU MDR 2017/745, ISO 14971, FDA regulations, design controls, risk management, validation, CAPA, NCRs, and supplier quality.

This role will serve as Management Representative and one of the Persons Responsible for Regulatory Compliance, partnering closely with Regulatory Affairs, Engineering, Clinical, Operations, suppliers, contract development organizations, Notified Bodies, FDA, and state regulatory agencies to ensure quality system compliance, product conformity, audit readiness, and successful regulatory approvals.

Key Responsibilities

Quality Management System Leadership

• Lead the development, implementation, maintenance, and continuous improvement of the Company Quality Management System.
• Develop and maintain the Quality Manual, critical SOPs, and quality system processes required to support regulatory readiness and commercial launch.
• Serve as Management Representative with responsibility for QMS documentation, effectiveness reporting, improvement planning, and promotion of regulatory and quality system awareness across the organization.
• Lead quality system activities supporting ISO 13485 certification, EU MDR compliance, FDA readiness, and applicable state regulatory expectations.

Regulatory Compliance & Audit Readiness

• Serve as one of the Persons Responsible for Regulatory Compliance, supporting product conformity prior to commercialization and confirming post-market surveillance obligations are met.
• Manage quality-related interactions with Notified Bodies, FDA, California Food and Drug Branch, critical suppliers, and contract development organizations.
• Lead and support internal, supplier, notified body, regulatory, and customer audits, including audit preparation, documentation, responses, and follow-up actions.
• Monitor evolving regulatory requirements, standards, guidance documents, and industry best practices applicable to Class III cardiac ablation technologies.

Quality Engineering & Product Development

• Provide Quality Engineering leadership throughout product and process development to ensure compliance, manufacturability, serviceability, testability, reliability, and conformance to product and quality system requirements.
• Support verification and validation activities for sterilization, biocompatibility, package integrity, shelf life, reliability, software validation, and electrical safety.
• Oversee product risk management files and ensure risk documentation remains aligned with design controls, clinical use, complaints, nonconformances, and post-market information.
• Manage Design History Files to ensure documentation is complete, accurate, inspection-ready, and aligned with cross-functional development activities.

Supplier Quality, CAPA & Continuous Improvement

• Manage critical suppliers on…