Regulatory Affairs Specialist - Katalyst Healthcares & Life Sciences
Madison, WI 53558
About the Job
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.
- 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.
Source : Katalyst Healthcares & Life Sciences
