Job Description

Position Title: Director Quality Assurance and Regulatory Affairs

Department: Quality Assurance and Regulatory Affairs

Reports to: CSO

Position Overview

The Director of Quality Assurance/Regulatory Affairs plays a key role in ensuring the traceable delivery of safe and effective cardiac 3D mapping and ablation products. This individual will lead the development and maintenance of a compliant quality management system (e.g., ISO 13485, MDSAP, Regulation (EU) 2017/745) and execute global regulatory strategies aligned with company objectives. Responsibilities include initiating design control, preparing regulatory submissions, overseeing post-market surveillance, and maintaining communication with global regulatory authorities.

Duties and Responsibilities

• Contribute to corporate strategic planning and objectives.
• Negotiate significant matters with senior leadership and influence decisions effectively.
• Collaborate across the organization to allocate resources and budget for a compliant quality management system.
• Develop and refine regulatory strategies for new and existing devices.
• Align quality procedures and regulatory strategies with business goals.
• Serve as the Management Representative and the Person Responsible for Quality and Regulatory Compliance (PRRC).
• Manage regulatory filings for facility and product approvals, responding to audits from global regulatory authorities, including the FDA (USA), ANVISA (Brazil), TGA (Australia), Health Canada, MHLW/PMDA (Japan), and selected Notified Bodies (EU).
• Monitor regulatory developments and recommend necessary company practice changes.
• Foster collaboration and respect among teams, physicians, consultants, and agencies.

Education, Experience and Skills Required

• Bachelor's or higher.
• 10+ years of experience in quality assurance and regulatory affairs within the medical device industry, including 5+ years in leadership.
• Successful internal, external, and supplier audits and certifications.
• Successful regulatory submissions, clearances, and approvals.
• In-depth knowledge of international quality system and regulatory requirements.
• Strong communication skills with the ability to manage priorities under pressure.
• Effective in planning, resource management, and adapting to contingencies.
• Ability to travel internationally.

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.

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