The Manager of Regulatory & Clinical Affairs manages the collection of information and documentation and compiles into submissions, license renewals, periodic updates and registrations to regulatory agencies. Manages the conduct of clinical trials by ensuring compliance with study protocols, FDA and other international regulations and overall corporate clinical objectives.
Comply with company’s quality system requirements as well as any applicable regulatory requirements
Comply with all health and safety regulations, policies, and work practices
Efficiently manage all aspects of Regulatory Affairs and Clinical Affairs.
Create and maintain regulatory filings such as IDE, 510(k), Technical File, and Medical Device License Application submissions
Organizes regulatory information and tracks and controls submissions. Reviews and advises on labeling for compliance with regulatory filings.
Reviews product changes for impact on regulatory filings worldwide.
Leads the Post-market Surveillance Program
Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to our commercial partners
Compile materials for license renewals, updates and registrations in a timely manner
Establish and maintain system for tracking changes in documents submitted to agencies or partners
Review labeling and labels for compliance with regulatory requirements
Maintain current knowledge of FDA and international regulation, guidance and standards applicable to company products
Manage assigned projects including resource allocation, budgeting, and assuring adherence to schedules
Responsible for clinical study management system and maintenance, ensuring quality trial results. System includes training documents, site specific instruction manuals, design of quality Case Report Forms, reporting methods for AEs, protocol deviations, method for tracking status of essential documents for each site, etc.
Preparation of clinical protocols and reports; and clinical sections of regulatory submissions (i.e., 510(k)s, IDE, PMA, and Technical Files)
Develop and oversee investigator training programs and manage the preparation of technical and scientific publications
Participate in the short- and long-term planning of new product opportunities
Maintain quality system, including design control and postproduction compliance.
Recruit, hire, train, manage, and develop Clinical and Regulatory staff members
Maintain superior knowledge of clinical environment and competitive technologies in addition to medical and technical developments related to company products
Coordinate activities with other team members to ensure compliance with protocols, company standard operating procedures and regulatory authority requirements
Serve as a liaison between clinical contacts (investigators and sites) and company
Education and /or Experience:
Minimum 5 years of Regulatory Affairs and Clinical Affairs in the medical device industry, with a minimum 2 years of experience in Post-market surveillance
Experience with outpatient procedures preferred
Clinical and regulatory experience with FDA Class II Medical Devices is mandatory