Senior Regulatory Affairs Specialist

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$93,000.00/yr - $/yr

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.

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.

• 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

• 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

• 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

• 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
• Employee Assistance Program
• An environment of belonging where everyone can thrive

Mid‑Senior level

Full‑time

Legal

Medical Equipment Manufacturing