Senior Regulatory Affairs Specialist

This position independently supports projects to bring new and modified medical devices to market and ensure ongoing compliance. This position participates on cross-functional teams, leads the development of global regulatory strategies, authors regulatory submissions, interacts with regulatory agencies/notified bodies, reviews design control documents and product labeling, and evaluates proposed device changes.

Requirements

• Representative of Regulatory Affairs on product development teams
• Evaluation of medical device regulations and development of global regulatory strategies
• Reviews and approval of design control documentation and product labeling
• Authoring of FDA submissions, EU technical files, and other regulatory documents
• Point of contact for FDA, EU notified bodies, and other regulatory agencies
• Independent review of product changes to ensure regulatory compliance
• Communication of changes to global regions and support of preparation of global notifications
• Understanding of fundamental global regulatory requirements and different regulatory pathways
• Staying informed of new regulations and changes to existing regulations
• Maintenance of regulatory databases and systems
• Support of regulatory body audits, CAPAS, and other compliance activities
• Review of advertising and promotional material
• Participation and leadership in training related to areas of expertise
• Mentorship of other regulatory colleagues