Senior Regulatory Affairs Specialist

SCIENTIA VASCULAR INC•West Valley City, UT

19d

About The Position

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 Vascular’s portfolio of marketed devices. The specialist will also offer guidance generally on regulatory matters.

Requirements

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

Nice To Haves

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

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
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