Principal Regulatory Affairs Specialist - Cardiac Ablation

Career Opportunities: Principal Regulatory Affairs Specialist - Cardiac Ablation (61964) Requisition ID 61964 -Posted - Posting Country (1) - Work Location (1) - Administration and Office - Unlimited - Full-time - Mid-Career - BIOTRONIK Principal Regulatory Affairs Specialist - Cardiac Ablation 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. About Us We are an innovative, fast‑moving start‑up developing next‑generation cardiac ablation catheter technologies. Our team is driven by scientific rigor, clinical insight, and a commitment to transforming arrhythmia care. As we prepare for major regulatory milestones in both the U.S. and EU, we are seeking a deeply experienced, hands‑on regulatory expert to lead our submission strategy and execution. Key Responsibilities Prepare and submit EU CE Mark applications, including technical documentation, clinical evidence requirements, and interact with Notified Bodies. Work with Quality to successfully pass MDR Stage 1 and 2 audits. Prepare and submit IDE applications, PMA submissions for cardiac ablation catheters. Develop regulatory strategies that align with product development, clinical plans, and commercialization timelines. Serve as the internal subject‑matter expert on global regulatory requirements for cardiac ablation technologies. Prepare and manage regulatory interactions, including Q‑submissions, pre‑subs, and formal meetings with FDA and Notified Bodies. Interpret and communicate regulatory changes, standards, and guidance documents relevant to electrophysiology and ablation devices. Support risk management activities, labeling development, and design documentation from a regulatory perspective. Maintain meticulous documentation and ensure audit‑ready regulatory files. Your Profile Education / Experience Requirements Minimum 7 years of hands‑on regulatory affairs experience specifically with cardiac ablation catheters (electrophysiology, RF, cryo, pulsed field, or related ablation modalities). Proven hands‑on (not management) track record of successfully receiving CE Mark under MDR for electrophysiology or ablation catheters. Demonstrated successful expertise in obtaining FDA PMAs for Class II/III cardiac devices. Deep understanding of GSPR, MDR regulations, risk management (ISO 14971), and relevant cardiac device standards. Experience working in a start‑up or fast‑paced development environment. Strong technical writing skills and the ability to translate complex engineering and clinical data into clear regulatory documentation. Excellent communication skills and confidence interacting with regulatory authorities. Bachelor’s degree in engineering, life sciences, or related field; advanced degree preferred. Additional Preferred Knowledge, Skills and Abilities Experience with novel energy modalities (e.g., PFA). Prior involvement in early‑stage product development and first‑in‑human submissions. RAC certification. Physical and Travel Requirements While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer for extended periods of time and communicate with co‑workers. Must be able to work a minimum of 40 hours/week. Minimum to no work‑from‑home opportunity. Must be able to work onsite at our Tustin, CA facility. No relocation support will be provided. Must be able to travel domestically, less than 20% of the time. Work Location This role follows a hybrid schedule and requires working onsite at our Tustin, CA office at least 50% of the time. What We Offer Competitive base salary, with a negotiable performance bonus. Opportunity to shape regulatory strategy for breakthrough cardiac technologies. A collaborative, mission‑driven environment where your expertise has immediate impact. BIOTRONIK EP CRC is dedicated to fair and equitable compensation practices. The base salary range for this position is $150,000 – 190,000 per year, based on experience and qualifications. In addition to base salary, BIOTRONIK EP CRC offers a bonus program and comprehensive benefits package, which includes health insurance, retirement plans, paid time off, and other perks. Compensation may vary depending on geographic location, skills, experience, and other factors. Location: Tustin, CA | Working hours: Full‑time | Type of contract: Unlimited Job ID: 61964BIOTRONIK CRC Inc. USA We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law. Please note that applications sent by post will only be returned if a sufficiently stamped self‑addressed envelope is included. #J-18808-Ljbffr