Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Responsibilities:
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.
Responsible for planning, managing, and implementing regulatory strategies and product submissions for the US FDA, EU notified body and other country specific regulatory bodies.
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.
Requirements:
Bachelor’s Degree in a related field
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.