Scientia Vascular
Senior Regulatory Affairs Specialist
Scientia Vascular, West Valley City, Utah, United States
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Senior Regulatory Affairs Specialist
role at
Scientia Vascular
Base pay range $93,000.00/yr - $131,000.00/yr
About Scientia Vascular Our mission is to save lives. Scientia Vascular is a leading innovator and manufacturer of endovascular medical devices. We use micromachining and micro‑fabrication processes to manufacture products that provide physicians with enhanced performance for optimal outcomes for their patients.
Job Position Summary The Senior Regulatory Affairs Specialist (hereafter: “the specialist”) who thrives in a fast paced, cross‑functional environment. They will be responsible for establishing regulatory strategies and provide input to management and cross‑functional teams for future product pipeline. They will perform activities necessary to comply with global regulation, primarily in the United States and the European Union. Specifically, the specialist will work to help establish systems and obtain regulatory approvals for new devices in development and will work to maintain approvals for Scientia Vascular’s portfolio of marketed devices. The specialist will also offer guidance generally on regulatory matters.
Primary 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 with regulatory requirements
Review labeling and marketing materials for compliance with regulatory requirements
Document post‑market device changes
Provide guidance with post‑market activities
Monitors compliance with existing regulations and upcoming or changing regulations
Assist with impact analysis of regulatory changes and produce status reports
Participate in processes to report, investigate, and address any issues of non‑compliance
Mentor team members on regulation review and application
Offer guidance on regulatory matters
Correspond and interface with regulatory authorities
Demonstrate ability to interpret and apply relevant regulations, standards, and guidance to ongoing company activities
Qualifications 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
Key Benefits We Provide
Medical, Dental, Vision insurance
Generous Paid Time Off (PTO)
Paid Parental Leave
Paid Holidays
401(k) 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
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Legal
Industries Medical Equipment Manufacturing
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Senior Regulatory Affairs Specialist
role at
Scientia Vascular
Base pay range $93,000.00/yr - $131,000.00/yr
About Scientia Vascular Our mission is to save lives. Scientia Vascular is a leading innovator and manufacturer of endovascular medical devices. We use micromachining and micro‑fabrication processes to manufacture products that provide physicians with enhanced performance for optimal outcomes for their patients.
Job Position Summary The Senior Regulatory Affairs Specialist (hereafter: “the specialist”) who thrives in a fast paced, cross‑functional environment. They will be responsible for establishing regulatory strategies and provide input to management and cross‑functional teams for future product pipeline. They will perform activities necessary to comply with global regulation, primarily in the United States and the European Union. Specifically, the specialist will work to help establish systems and obtain regulatory approvals for new devices in development and will work to maintain approvals for Scientia Vascular’s portfolio of marketed devices. The specialist will also offer guidance generally on regulatory matters.
Primary 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 with regulatory requirements
Review labeling and marketing materials for compliance with regulatory requirements
Document post‑market device changes
Provide guidance with post‑market activities
Monitors compliance with existing regulations and upcoming or changing regulations
Assist with impact analysis of regulatory changes and produce status reports
Participate in processes to report, investigate, and address any issues of non‑compliance
Mentor team members on regulation review and application
Offer guidance on regulatory matters
Correspond and interface with regulatory authorities
Demonstrate ability to interpret and apply relevant regulations, standards, and guidance to ongoing company activities
Qualifications 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
Key Benefits We Provide
Medical, Dental, Vision insurance
Generous Paid Time Off (PTO)
Paid Parental Leave
Paid Holidays
401(k) 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
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Legal
Industries Medical Equipment Manufacturing
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