Scientia Vascular · 1 day ago
Senior Regulatory Affairs Specialist
West Valley City, UT
Full-time
Onsite
Mid, Senior Level
$93K/yr - $131K/yr
4+ years expScientia Vascular is a leading innovator and manufacturer of endovascular medical devices, dedicated to saving lives. The Senior Regulatory Affairs Specialist will establish regulatory strategies, ensure compliance with global regulations, and maintain approvals for the company's medical device portfolio.
Health CareManufacturingMedicalMedical Device
Responsibilities
Supporting New Product Development
Develop and execute regulatory strategies for obtaining approval for new products in development
Lead and prepare and submit regulatory filings
Register new products as required
Maintain necessary FDA product databases, facility registrations and small business registrations
Maintain international technical documentation
Review product and quality system changes for compliance to regulatory requirements
Review labelling and marketing materials for compliance to regulatory requirements
Document post-market device changes
Provides guidance with post-market activities
Monitors compliance with existing regulations and upcoming or changing regulations
Assist with impact analysis of regulatory changes and produces status reports
Participates in processes to report, investigate, and addresses any issues of non-compliance
Mentor team members on regulation review and application
Offer guidance on regulatory matters
Correspond and interface with regulatory authorities
Demonstrated ability to interpret and apply relevant regulations, standards and guidance to ongoing company activities
Qualification
Required
BA/BS degree in Biology, Science, Engineering, Math or related field of study or equivalent
Minimum of 4 years of experience in a medical device regulatory affairs role
Computer proficiency, Microsoft Word and Excel in particular
Work individually and self-starter
Excellent analysis, writing, and communication skills
Ability to communicate with cross-functional teams
Ability to appropriately manage time and prioritize tasks
FDA submission experience
Preferred
Demonstrate knowledge of a regulated environment
Some history of authoring or contributing to successful 510(k), PMA, and/or CE Mark submissions
Pre-submission preparation and/or FDA interactions
Ability to understand technical documents and drawings
Benefits
Medical, Dental, Vision insurance
Generous Paid Time Off (PTO)
Paid Parental Leave
Paid Holidays
401k Plan (with a generous employer match)
Life Insurance (company paid)
Short-Term & Long-Term Disability Insurance (company paid)
Subscription to Calmhealth.com
Employee Assistance Program
An environment of belonging where everyone can thrive
Company
Scientia Vascular
Scientia Vascular is a medical device company that provides endovascular devices that assist in complex and minimally invasive procedures.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
$89MKey Investors
Piper Jaffray Merchant BankingVivo Capital
2024-09-09Private Equity· $14M
2022-01-01Debt Financing· $25M
2021-05-31Private Equity· $50M
Leadership Team
John Lippert
Chief Technology Officer
Recent News
2025-10-23
2025-04-02
Company data provided by crunchbase