SynCardia Systems, LLC · 16 hours ago
Senior Regulatory Affairs Specialist
Tucson, AZ
Full-time
Onsite
Senior Level
7+ years expSynCardia Systems, LLC is a company that develops and commercializes the SynCardia Total Artificial Heart, the only FDA-approved total artificial heart. The Senior Regulatory Affairs Specialist role is crucial for ensuring that product processes meet regulatory standards, supporting patient safety, and advancing quality systems in alignment with FDA and international requirements.
Health CareManufacturingMedicalWellness
Responsibilities
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
Qualification
Required
Bachelor's degree (or equivalent)
7–10 years of experience in regulatory affairs experience
2+ years working with Class III medical devices
Strong written and verbal communication skills
Preferred
Experience with Class III medical devices preferred
Experience supporting FDA or international regulatory submissions
Background in medical devices, biotech, pharma, or aerospace
Company
SynCardia Systems, LLC
SynCardia Systems, LLC, a Picard Medical Company, is headquartered in Tucson, AZ.
51-200 employees
H1B Sponsorship
SynCardia Systems, LLC has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (2)
2023 (2)
2021 (2)
Funding
Current Stage
Growth StageTotal Funding
$39.42MKey Investors
SWK Holdings
2021-09-28Acquired
2014-09-15Series Unknown· $6.42M
2013-12-23Series Unknown· $14M
Leadership Team
Don Webber
Chief Executive Officer
Patrick NJ Schnegelsberg
Chief Executive Officer
Recent News
Seattle TechFlash
2026-01-23
Company data provided by crunchbase