- Family Dollar (Chesapeake, VA)
- …industries (pharmaceutical or medical device industry preferred). . Working knowledge of FDA Quality Systems (cGMP) and regulatory requirements (eg, ... will assist in completing the day-to-day responsibilities of the Quality Systems Manager for product quality , safety,...result of a complaint or event. . Oversee the regulatory notification process (eg, market actions such as Medical… more
- Family Dollar (Chesapeake, VA)
- …industries. (pharmaceutical or medical device industry preferred). + Working knowledge of FDA Quality Systems (cGMP) and regulatory requirements (eg, ... **Family Dollar** ** Quality Assurance Associate** _About Us_ Based in Chesapeake,...purchasing specifications against applicable standards to confirm conformance with regulatory requirements. + Assist in the vendor/supplier qualification program,… more
- Praxair, Inc - a Linde Company (Fresno, CA)
- …- $112,200 yearly (commensurate with experience) What you will be doing: + Provide FDA regulatory and Quality systems support to assigned locations within ... Quality personnel to ensure Manufacturing and Warehousing locations meet or exceed FDA and corporate Quality requirements. This employee will ensure … more
- Wacker Chemical (Ann Arbor, MI)
- …Affairs Specialist- FDA Food 1 1. This position is responsible for leading FDA regulatory product compliance reviews for Food Additive, Food Contact, and ... Contact, and Dietary Supplements, including maintaining our food facility registrations. The FDA Regulatory Affairs Specialist will evaluate and respond to… more
- Abeona (Cleveland, OH)
- …team management or leadership experience. + Deep knowledge of cGMPS, ICH Q9 ( Quality Risk Management), FDA regulatory expectations. + General knowledge ... or leadership experience. + Deep knowledge of cGMPS, ICH Q9 ( Quality Risk Management), FDA regulatory expectations. + General knowledge of aseptic… more
- Boehringer Ingelheim (Ridgefield, CT)
- …clinical trial design and results, if available, taking into account US regulatory labeling precedence and FDA comments/guidance. + Pre-evaluations and External ... regulatory strategy and goals for formal meetings with FDA that is aligned with project teams and RA...and distribution in the US of critical safety or quality communications (including DHCP letters) for assigned projects/products, with… 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 ... risk for wearable-based health technology. + Provide strategic counsel on FDA oversight, regulatory submissions, and compliance strategies for biometric… more
- Houston Methodist (Houston, TX)
- …and the International Conference on Harmonization (ICH). This position communicates with regulatory affairs office for FDA submissions across multiple studies of ... **SERVICE ESSENTIAL FUNCTIONS** + Ensures compliance of general and study-specific regulatory and/or safety-related processes with SOP's, FDA , GCP, NIH… more
- Glenmark Pharmaceuticals Inc., USA (Elmwood Park, NJ)
- Associate Director, Regulatory Affairs Department: Regulatory Affairs Location: Elmwood Park, NJ START YOUR APPLICATION ... communication to support both internal and external customers (globally) including the US FDA . Job Responsibilities Note: These statements are not intended to be an… more
- Boehringer Ingelheim (Ridgefield, CT)
- …personnel, will liaise with FDA in written communication and participate in FDA meetings on regulatory issues. Will support/assist in the preparation of ... NDA Field Alert Report: Contribute to assessment of potential quality defects, technical product complaints and/or patient complaints and...cross-functional teams for FDA interactions on regulatory issues and provide… more