Senior Regulatory Affairs Specialist

Job Description

Job Description

Description:

Tucson, AZ | Full-time | On-site

About SynCardia Systems LLC

SynCardia develops, manufactures, and commercializes the SynCardia Total Artificial Heart (STAH), the only commercially available total artificial heart approved by both the U.S. Food and Drug Administration (FDA) and Health Canada. SynCardia is a wholly owned subsidiary of Picard Medical Inc. (NYSE: PMI) which became a publicly traded company on August 29, 2025.

Why this role matters:

At SynCardia our mission is to transform and save lives through life sustaining Total Artificial Heart technology. This role is essential to delivering on that mission by ensuring that our product’s processes and systems consistently meet the highest standards of safety, reliability and performance. You will help strengthen and advance quality systems and cross functional execution in alignment with FDA, ISO and international regulatory requirements. Your work directly supports patient safety clinical outcomes and global regulatory success while reinforcing a culture of quality excellence across the organization.

What you will do:

• Prepare regulatory submissions including PMAs, supplements, annual reports, and responses to FDA communications.
• Research regulatory requirements and track commitments.
• Participate in Design Control activities with Engineering.
• Review device, labeling, and manufacturing changes.
• Approve promotional materials and labeling.
• Lead assigned regulatory project teams.

What we are looking for:

Required

• Bachelor’s degree (or equivalent)
• 7–10 years of experience in regulatory affairs experience
• 2+ years working with Class III medical devices
• Experience with Class III medical devices preferred
• Strong written and verbal communication skills

Nice to have

• Experience supporting FDA or international regulatory submissions
• Background in medical devices, biotech, pharma, or aerospace

Why you will love working here:

• Mission-driven work with direct patient impact
• Collaborative, cross-functional teams
• Opportunity to lead regulatory strategy for Class III medical devices

Work environment:

Office-based role with minimal noise, requiring extended periods of sitting, typing, and occasional lifting to 25 pounds.

Industry:

Medical equipment manufacturing

Employment type:

Full-time