Principal Regulatory Affairs Specialist - Cardiac Ablation

The Principal Regulatory Affairs Specialist will serve as the company’s 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 individual‑contributor role with no managerial responsibilities
. The ideal candidate thrives in a start‑up 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 hands‑on regulatory experience specifically in cardiac ablation catheters will not be considered.

• 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.

• 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.

• Experience with novel energy modalities (e.g., PFA).
• Prior involvement in early‑stage product development and first‑in‑human submissions.
• RAC certification.

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.

This role follows a hybrid schedule and requires working onsite at our Tustin, CA office at least 50% of the time.

• 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,…