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Regulatory Affairs Specialist
4 months ago
Job Description
The primary purpose of this position is to strategically plan, execute and provide oversight to regulatory activities necessary to obtain and maintain regulatory approvals within the United States and International markets and ensure compliance with relevant US, EU, ISO standards and other regulatory requirements based on geography and product.
Accountabilities & Responsibilities:
• Adheres to Integer’s Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
• Works independently, receives minimal guidance
• Acts as a resource for colleagues with less experience; may direct the work of other staff members
• Responsible for planning, managing and implementing regulatory strategies and product submissions for the US FDA, EU notified body and other country specific regulatory bodies. Provides strategic input. Participates on Product Development teams, providing a high level of experience in regulatory, strategy, timelines, and direction.
• Prepares US and International submissions for Medical Devices and works with government agencies and/or distributors to obtain product approval/clearance.
• Serves as informational resource for all departments, assists in keeping company informed of US and International regulatory requirements. Ensures relevant International, ISO and FDA requirements are met, as required and ensures accuracy of submission information.
• Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance
• Initiates Free Sales Certificate requests and product release authorizations.
• Support post-market regulatory compliance activities, which includes review and assessment of change requests to determine effect of product changes on US and International regulatory strategy and submissions per standard procedures.
• Evaluates post-market incident reports and determine MDR requirements.
• Develops and maintains regulatory status documents and submission procedures.
• Assists with recall/retrieval documentation and other activities.
• Identifies, investigates, evaluates and implements, as appropriate, new methodologies associated with product quality and quality systems.
• Performs other functions as required.
Education & Experience:
• Minimum Education: Bachelor’s Degree in a related field
• Minimum Experience: 3 years of US and International medical device, IVD or pharmaceutical regulatory submission/approval experience to include US FDA, EU MDD/AIMD and/or EU MDR, Japan PMDA, Australia TGA and China CDA; or 2 years of experience with Master’s in Regulatory Affairs.
Knowledge & Skills:
• Special Skills: Ability to research, compile, summarize and present information. Ability to work through issues with customers.
• Specialized Knowledge: Knowledge of US FDA Quality System Regulations and ISO Requirements. Knowledge of applicable laws which regulate medical device manufacturers.
• Other: Skill in working with computers and experience with Microsoft Office Suite
