Senior Regulatory Affairs Specialist jobs in United States
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SynCardia Systems, LLC · 7 hours ago

Senior Regulatory Affairs Specialist

positionTucson,AZ,US
timeFull-time
remoteOnsite
senioritySenior Level
date7+ years exp

SynCardia Systems, LLC develops and commercializes the SynCardia Total Artificial Heart, the only FDA-approved total artificial heart. The Senior Regulatory Affairs Specialist will ensure that product processes meet safety and performance standards, preparing regulatory submissions and leading project teams to support patient safety and regulatory success.

Health CareManufacturingMedicalWellness
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H1B Sponsor Likelynote

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

Regulatory submissionsClass III medical devicesRegulatory affairs experienceCommunication skillsBackground in medical devices

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

Company

SynCardia Systems, LLC

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SynCardia Systems, LLC, a Picard Medical Company, is headquartered in Tucson, AZ.
dateFounded in 2001
location
Tucson, Arizona, USA
people-size51-200 employees
web-link
http://www.syncardia.com/

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 Stage
Total Funding
$39.42M
Key Investors
SWK Holdings
2021-09-28Acquired
2014-09-15Series Unknown· $6.42M
2013-12-23Series Unknown· $14M

Leadership Team

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Don Webber
Chief Executive Officer
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Patrick NJ Schnegelsberg
Chief Executive Officer
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Recent News

Seattle TechFlash
Arizona Tech Week 2026: State's inaugural event set to showcase growing innovation ecosystem
2026-01-23
GlobeNewswire
SynCardia and Hydrix Enter into Development Collaboration to Advance the Emperor, SynCardia’s Next Generation Total Artificial Heart
2026-01-12
TradingView
Hydrix secures $2.5m deal to collaborate on development of SynCardia’s total artificial heart technology
2026-01-08
Company data provided by crunchbase