The Manager of Regulatory Affairs will plan, organize, and implement strategies and activities required to procure regulatory approval for new and revised product lines. He/she will ensure regulatory compliance to all US and EU requirements, corporate policies and procedures regarding submissions and other requirements for market approval of medical devices/combination products. The Manager of Regulatory Affairs will provide greater support to the group by taking on more projects of greater complexity under minimal supervision.
The Manager of Regulatory Affairs has extensive knowledge performing their function within the Food & Drug Administration (FDA) Quality System Regulation (QSR), 21 CFR, International Organization of Standardization (ISO) 13485:2003, ISO 14971:2007, and Medical Device Directive (MDD) 93/42/EEC. The incumbent has the ability to take strategic direction and establish efficient and regulatory compliant processes throughout the organization and with strong communication skills at all levels
DUTIES & RESPONSIBILITIES
Assure regulatory compliance with internal procedures and external standards.
Spearhead Unique Device Identifier (UDI) activities for companywide implementation.
Provide regulatory support on product development teams through the product life cycle on product project teams (e.g., developing regulatory strategies, timeline development, change control and preparing submission related documents)
Provide regulatory assessments for manufacturing, design changes, and validation activities
Provide regulatory input in quality system assessments, product development, and complaint/MDR/Vigilance handling system.
Review and approve test protocols to support regulatory submissions.
Support the Think Quality Policy and Quality Management System.
Provide input and reviews Design Control documentation such as: Risk Management, Design verification, design validation, shelf life studies, pre-clinical studies, and clinical studies.
Identify guidance documents, international standards and consensus standards, and risks and assist product development teams with their interpretation.
Review and approve product labeling, claims, training materials and advertising/promotional materials.
Track and maintain regulatory registrations and product blocking lists to ensure valid international regulatory clearances, sales, and commerce implications.
Perform vigilance activities
Assist in negotiations with the FDA or other regulatory agencies.
Maintain regulatory affairs product files to support compliance with regulatory requirements.
Review domestic and international Marketing Advertising and Promotional materials to ensure valid label claims are consistent with US and international rules and regulations.
Handle FDA customs import/export requests, customer service needs, and other requests from internal customers
Develop, document, and implement a regulatory strategy plan to support product development and company goals
Provide continual regulatory updates to the Management Team to ensure that processes needed for the quality system regulation are established, implemented, and maintained.
Establish and maintain regulatory information systems both electronically and hard copy.
Responsible for Medical Device Directive.
Serves as communicator with all regulatory agencies for both oral and written communications and reporting, ensuring reports are compiled, approved, and distributed to appropriate internal personnel as well as external agencies. Also manages the preparation and quality check of all regulatory submissions to regulatory agencies.
Perform other duties as assigned.
Performance management of employees in the RA department
Awareness of international regulatory requirements and quality systems.
6+ years Regulatory Affairs medical device industry experience.
THINK Surgical, Inc. develops, manufactures and markets the only active robotic surgical system for orthopaedic surgery. The system includes two components: a 3D preoperative planning workstation for preoperative planning, and a computer assisted tool utilized for precise cavity and surface preparation for hip and knee replacement surgeries. The systems have been used in thousands of joint replacements worldwide core technology.