Regulatory Affairs Specialist

ATEC Spine has an exciting opportunity for a Regulatory Affairs Specialist to work on-site at our location in San Diego, California. The Regulatory Affairs Specialist will support the development of submissions for domestic and international clearances for spine surgery products; as well as the support of daily activities related to product design teams, change control, and regulatory product submissions.

Essential Duties and Responsibilities

• Collaborates as a core team member on new product development teams. Determines and documents appropriate regulatory strategy for proposed new products. Supports design control activities.
• Supports and assists in FDA 510(k) premarket notifications and ROW regulatory submissions.
• Coordinates responses to regulatory agencies as part of the submission and approval process.
• Evaluates design changes to products to determine impact to submissions and potential need for additional submissions.
• Assists with post-market surveillance evaluation, trending, and reporting, including updates to risk management (FMEA) process.
• Reviews and approves labeling and promotional materials for compliance with applicable regulations and policies.
• Researches sources of regulatory information (e.g., regulatory agency websites, standards organization websites, literature, trade sheets, competitor information, etc.).
• Provides department support during internal and external audits.
• Develops and maintains procedures and/or work instructions for product registrations.
• Maintains FDA establishment listings and registration.
• Other duties as assigned.