Position: Quality Assurance Regulatory Affairs Manager (IVDR Experience Required)
About: Ansh Labs, a company specializing in developing, coordinating, implementing, and maintaining quality management processes for the production of products in adherence to regulatory requirements and standards set forth in their quality manual and SOPs. The company monitors manufacturing, development, quality, and regulatory processes to ensure compliance with FDA and international regulations.
Requirements: Bachelors/Masters in Biotechnology or related field; 5+ years of experience in a Regulatory or Quality position with at least 2 years in a medical device company; strong knowledge of US FDA Quality System Regulations 21 CFR 820, ISO 13485, and EU (CE) Regulations (IVDD/IVDR); proficiency in quality compliance, such as CAPA, Root Cause Analysis, Validation, and Process Controls; ability to work well within cross-functional teams; technical writing ability
Benefits: health insurance, dental insurance, vision insurance, 401(k), full-time position with a work schedule of Monday-Friday, 8:30 AM – 5:30 PM
