Regulatory Affairs Specialist

About the role

Plans, organizes and implements strategies and activities required to procure regulatory approval for new and revised product lines. Coordinates and prepares regulatory submissions, including 510(k) premarket notifications, EU MDR Technical Files and other international registrations. Ensure compliance to all US, EU and international requirements and company policies and procedures regarding submissions and other requirements for market approval of medical devices.

Responsibilities

• Authors, compiles, and submits regulatory documents to obtain approval to market new or modified products, including 510(k) premarket notifications and international submissions.
• Prepares, maintains and submits Technical Documentation and Declarations of Conformity for CE-marked products under EU MDR 2017/745.
• Prepares and maintains international product registrations.
• Prepares and updates US FDA product listings and establishment registrations.
• Monitors publications and activities of FDA, EU Commission, and international regulatory bodies to identify and respond to new or revised regulatory requirements affecting company products.
• Interprets existing and emerging regulatory requirements as they relate to company products and procedures; communicates updates to appropriate personnel and management.
• Identifies and communicates changes to domestic and international regulatory requirements in a timely manner to support proactive compliance planning.
• Ensures label claims and content of promotional and marketing materials comply with domestic and international regulatory requirements; reviews and recommends appropriate changes.
• Provides regulatory support to new product development teams to ensure US and international regulatory requirements are incorporated into the development process from design input through commercialization.
• Performs and documents regulatory assessments for modifications to existing devices, collaborating with marketing, R&D, and operations on proposed changes.
• Supports marketing and new product development in regulatory assessments of proposed labeling, design, or manufacturing changes.
• Collaborates with engineering and operations teams on design controls, validation activities, and technology transfers.

Requirements

• Bachelor’s degree or higher in a life science, engineering, or related discipline from an accredited institution.
• Minimum of