- Terumo Medical Corporation (Elkton, MD)
- …master validation plans, validation protocols, inspection plans and quality /regulatory compliance operating procedures to meet FDA (Food and Drug ... , and productivity with the end result of producing a better quality product more efficiently. Ensure compliance to TerumoA cents € (TM) s quality policy,… more
- embecta (Parsippany, NJ)
- …standards and regulatory requirements, including FDA and ISO standards. The Quality Compliance Auditor plays a strategic role in maintaining embecta's ... varying needs of our diverse and global employees. The Quality Compliance Auditor is a critical role...the Quality Management System (QMS) to ensure compliance with FDA regulations, ISO 13485, ISO… more
- Oura (San Francisco, CA)
- …privacy and regulatory compliance with commercial objectives. What you will do: FDA & Global Regulatory Compliance : + Serve as the primary legal advisor ... on FDA , EU MDR, and other global health ...product development, clinical validation, and market positioning. + Oversee compliance with Quality System Regulation (QSR) and… more
- Houston Methodist (Houston, TX)
- …and off site. + May assist in the preparation of periodic reports for FDA . ** QUALITY /SAFETY ESSENTIAL FUNCTIONS** + Provide routine updates and reporting to the ... At Houston Methodist, the Regulatory Compliance Specialist position is responsible for coordinating and...Institute Institutional Review Board (IRB), Food and Drug Administration ( FDA ) Code of Federal Regulations (CFR), and the International… more
- Patterson Companies, Inc. (St. Paul, MN)
- …responsible for maintaining and managing the daily operations of the Patterson Quality Management System. Manages compliance activities with responsibility for ... supplier controls. **A Day in the Life of a Quality Systems Compliance Specialist II:** + Oversees...management systems and regulatory submission requirements, preferably in an FDA -regulated environment ( FDA 21 CFR Part 820… more
- Fotona (Irving, TX)
- …resilience in a dynamic, fast-paced environment. Key Leadership Responsibilities: Regulatory & FDA Compliance Strategy + Serve as the organizational lead for ... excellence is earned from its dedication to R&D, unparalleled quality , reliability, ease of use, and durability. Fotona is...life sciences, or healthcare sector. + Deep expertise in FDA compliance , inspection readiness, and regulatory liaison.… more
- Charles River Laboratories (Rockville, MD)
- …a career that you can feel passionate about. **Job Summary** The Senior Specialist, Quality Systems and Compliance is responsible for providing oversight to the ... Quality Management System for compliance with applicable CGMP regulations. This includes but is...working knowledge and experience with the practical implementation of FDA , EMA and ICH regulations and guidelines. + Experience… more
- Schwan's Company (Minneapolis, MN)
- …it's a seat at the table! Are you a seasoned food safety and quality compliance leader passionate about driving regulatory excellence across the supply chain? ... Individual (PCQI), providing expert guidance on regulatory requirements, product safety, labeling compliance (USDA/ FDA ), and special claims to support safe and… more
- Roche (Indianapolis, IN)
- …Primary responsibilities include leading a team of high performing regulatory compliance professionals and managing FDA regulatory matters concerning advertising ... squads, taking a leading role in navigating complex situations within the quality and regulatory compliance landscape to deliver solutions that enable… more
- Integra LifeSciences (Braintree, MA)
- …what's possible and making headway to help improve outcomes. The Senior Quality Compliance Specialist -Training will create and conduct training programs ... matrices with each of the groups to ensure both compliance and business needs can be met, including appropriate...of learning management software. + Experience in GMP and quality systems regulations ( FDA QSRs, ISO 13485:2016,… more