Enchannel Medical is redefining the boundaries of electrophysiology with our next-generation DePolar™ mapping system and integrated NanoAblate™ PFA platform. Driven by our global mission to enhance the quality-of-life of cardiac arrhythmia patients, our discerning technology, paired with our passion for innovation, leads to enduring outcomes.

Position Overview

The Regulatory Specialist, Senior Staff will support the preparation and execution of regulatory submissions and quality system initiatives for medical devices, including IDE, 510(k), and PMA filings. Collaborates cross-functionally with engineering, R&D, quality, and manufacturing teams to ensure regulatory compliance and successful certification efforts.

Duties and Responsibilities   

The following are the major responsibilities needed for the role.  Additional responsibilities, tasks, and duties will be assigned and required as needed.

• Support IDE submissions under the combined leadership of Quality Assurance, Regulatory Affairs, and Clinical Affairs, including documentation, clinical-site coordination, and FDA interactions.
• Prepare and submit 510(k), PMA, and De Novo applications.
• Organize and support communications with FDA, Notified Bodies, and other global regulatory authorities, including Q-Sub, Pre-Sub, audit preparation, and response.
• Collaborate with Clinical Affairs to define, establish, manage, and attain regulatory compliance across all clinical-trial sites.
• Collaborate with R&D, Quality Assurance, and Manufacturing teams to maintain regulatory compliance throughout all product lifecycles.
• Contribute to the development of regulatory strategy and maintain submission timelines.
• Support establishment and maintenance of the Quality Management Systems (QMS) that will be certified to ISO 13485 and EU MDR standards.
• Participate in internal and external audits, including CAPA support and documentation.
• Provide input and support for Product Project Regulatory Coordinator (PPRC) activities or similar cross-functional regulatory tasks.
• Ensure that regulatory requirements are met during design control, risk management, and change control processes.
• Support and lead procedures and documentation for engineering-orders and/or change-orders and/or design-orders for product function, features, materials, hardware, firmware, software.

Education, Experience and Skills Required

Below are the minimum skills, formal education, certifications or training, and practical experience required to perform the general functions and duties of the role. 

• Bachelor’s degree in life sciences, engineering, or related field (Master’s or RAC certification preferred).
• Minimum 8+ years of experience in Regulatory Affairs within the medical device industry.
• Experience supporting and leading IDE, 510(k), and PMA submissions with successful clearances and approvals.
• Hands-on and successful experience with FDA and Notified Body interactions, including audits and inspections with certification issuances for ISO 13485 and CE. 
• Experience in establishing regulatory requirements that apply on multiple, international clinical sites in accordance with ISO 14155.
• Working knowledge of ISO 13485, ISO 14155 EU MDR, and FDA QSR requirements.
• Proficiency in collaborating cross-functionally with R&D, Quality Assurance, and Manufacturing teams.
• Experience in or exposure to PPRC responsibilities.
• Strong organizational and communication skills, with the ability to manage multiple priorities
• Strong experience with NCMR and CAPA process, investigation, and closure

Our pay ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum new hire pay for the position located in California. Within the range, individual pay is determined by location, additional factors, including job-related skills, experience, and relevant education or training. 

EnChannel Medical is an E-Verify and equal opportunity employer. We believe in hiring a diverse workforce and sustaining an inclusive, people-first culture. We are committed to non-discrimination on any protected basis, such as disability and veteran status, or any basis covered under acceptable law.

  Only qualified candidates will be contacted. 

JOB CODE: 1375