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

BIOTRONIK is a globally recognized leader in the development, manufacturing, and distribution of advanced cardio and endovascular implants, catheters, and medical devices centered around cardiac rhythm management, electrophysiology, and vascular intervention. Headquartered in Berlin, Germany, BIOTRONIK is committed to delivering innovative, high-quality medical solutions that significantly improve patient outcomes worldwide. Their products and technologies are rooted in the latest research and cutting-edge development, supported by a highly skilled workforce dedicated to clinical excellence and technological progress. As a company, BIOTRONIK prioritizes collaborative, results-driven environments that foster employee competence and innovation, making it a prominent and trusted name in the medical device industry.

Within BIOTRONIK's California Research Center Electrophysiology (CRC EP, Inc.) based in Tustin, CA, a specialized business unit is pioneering pulsed-field cardiac ablation (PFA) technology, innovative solutions aimed at treating atrial fibrillation. The CRC EP team has successfully completed First-in-Human clinical trials that validate this promising technology, positioning BIOTRONIK at the forefront of regulatory approval processes and the commercial release of breakthrough cardiac treatments in various global territories. This pioneering environment fosters a culture of technical expertise and scientific innovation, offering unique opportunities for professionals passionate about advancing cardiac care.

The Principal Clinical Research Analyst - Class III Medical Devices (EU MDR Clinical Affairs Expert) role at BIOTRONIK CRC EP represents a critical leadership position focused on clinical evaluation, evidence generation, and ensuring regulatory compliance for Class III medical devices, including cardiac ablation catheters and generators. This position is suited for professionals with extensive experience—more than seven years—in clinical affairs, clinical research, and regulatory support within medical device settings, with particular emphasis on the European Union Medical Device Regulation (EU MDR 2017/745). The Principal Clinical Research Analyst will serve as a subject matter expert, steering clinical evaluation and evidence strategies, and collaborating closely with Regulatory Affairs, Quality, and Engineering teams to maintain clinical compliance throughout all phases of the product lifecycle.

The responsibilities encompass leading the development and maintenance of Clinical Evaluation Reports (CERs) in line with EU MDR Annex XIV and relevant MEDDEV guidance, crafting robust clinical evidence strategies, supporting regulatory submissions, lifecycle management activities, and guiding post-market surveillance activities including PMS, PMCF, and PSUR. This role also involves designing and overseeing clinical investigations, post-market follow-up programs, conducting systematic literature reviews, and advanced clinical data analysis. The Principal Clinical Research Analyst will offer statistical interpretation, scientific rationale, and present findings to executive leadership and regulatory bodies, providing strategic clinical expertise and ensuring regulatory readiness.

This full-time position is based in Tustin, CA, and follows a hybrid work schedule requiring onsite presence with minimal remote flexibility. The role demands international and domestic travel up to 25% for audits, regulatory meetings, and other business engagements. BIOTRONIK offers competitive compensation, with a base salary ranging from $165,000 to $185,000 annually, complemented by a negotiable performance bonus and a comprehensive benefits package. The role presents an exceptional opportunity to contribute strategically to the regulatory and clinical success of cutting-edge medical technologies within a collaborative, mission-driven environment that values employee expertise and impact.