Senior Regulatory Affairs Specialist

About Scientia Vascular:

Our mission is to save lives. Scientia Vascular is aleading innovator and manufacturer of endovascular medical devices. We usemicromachining and microfabrication processes to manufacture products thatprovide physicians with enhanced performance for optimal outcomes for theirpatients.

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 team for future product pipeline. They will be performing 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 Vasculars portfolio of marketed devices. The specialist will also offer guidance generally on regulatory matters.

Primary Responsibilities:

The senior regulatory affairs specialist will be responsible for the following:

• 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

Maintaining Marketed Device Portfolio

• 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

General

• 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

Qualifications

• 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
• 401k 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