Principal Regulatory Affairs Specialist - Cardiac Ablation

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 companys 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, fastmoving startup developing nextgeneration 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, handson regulatory expert to lead our submission strategy and execution.

The Principal Regulatory Affairs Specialist will serve as the companys primary expert for global regulatory submissions, with a strong focus on EU CE Mark and US FDA pathways for cardiac ablation catheters . This is a senior individualcontributor role with no managerial responsibilities . The ideal candidate thrives in a startup environment, is comfortable rolling up their sleeves, and brings extensive, direct experience navigating the regulatory landscape for electrophysiology and ablation devices.

Candidates without at least 7 years of handson regulatory experience specifically in cardiac ablation catheters will not be considered.

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 subjectmatter expert on global regulatory requirements for cardiac ablation technologies.
• Prepare and manage regulatory interactions, including Qsubmissions, presubs, 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 auditready regulatory files.

Your Profile

Education / Experience Requirements

• Minimum 7 years of handson 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 startup or fastpaced 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.
• Bachelors 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 earlystage product development and firstinhuman submissions.
• RAC certification.

Physical and Travel Requirements

The physical demands described within this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• 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 .
• Comprehensive benefits package.
• Opportunity to shape regulatory strategy for breakthrough cardiac technologies.
• A collaborative, missiondriven 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.

Are you interested? Please apply online through our application management system! We are looking forward to welcoming you.

Location: Tustin, CA | Working hours: Full-time | Type of contract: Unlimited

Apply now under: www.biotronik.com/careers

Job ID: 61964 BIOTRONIK 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.