Regulatory Professional

Responsibilities: Provide regulatory support to product development core teams working on new or existing products Review and approve verification/validation and clinical/nonclinical protocols and reports in support of product development efforts Develop regulatory plans to address domestic and international requirements for new product development efforts or proposed modifications to existing products Perform and document regulatory assessments for proposed modifications to existing devices Develop and/or revise regulatory policies and procedures Prepare and maintain technical files or design dossiers in support of CE mark for EU products Implement and maintain product-specific Core Dossier documentation used to support international product registrations Provide general support for international product registrations and regulatory submissions Prepare FDA PMA, 510(k), and IDE submissions and annual reports Maintain global adverse event reporting process (including MDR, vigilance, etc.) Monitor activities/publications of FDA and international regulatory bodies to identify and respond to new or revised regulatory requirements Support Risk Management and labeling development activities, as required Review product labels and advertising/promotional materials for accuracy, consistency, and regulatory compliance, as required Represent Regulatory Affairs during FDA inspections or other government agency audits, as required Respond to government agency requests for device information, as required Implement post-market surveillance programs, as required Coordinate product recall efforts, as required
REQUIREMENTS
Education and/or Experience: Bachelor’s Degree (preferably in the science or legal field) 5-7 years experience in Regulatory Affairs PMA and/or 510(k) submission experience International device registration experience (preferably EU, Canada, Asia, etc.)