- Aerotek (St. Paul, MN)
- …and adjust priorities based on demand and capacity. + Ensure compliance with FDA regulations, ISO standards, and company quality systems. + Document production data, ... of production planning, scheduling, and workflow management. + Working knowledge of FDA regulations, GMP, and quality system standards. + Ability to track and… more
- Terumo Medical Corporation (Elkton, MD)
- …be to support product development prototype evaluations, or could be submitted to the FDA to support new product clearance or claims. 10. Performs other job related ... cross-functional interactions needed for the development of new products within FDA design control guidelines. o Demonstrated understanding of cardiology and… more
- Cordis (Irvine, CA)
- …and maintain the microbiology strategy in alignment with combination product regulatory requirements ( FDA , EU MDR, ISO). + Establish, build, mentor and manage a team ... in relation to microbiology, this includes PMA direct support, FDA inspections as the microbiology SME for a combination...environments. + Strong working knowledge of GMP, ISO 13485, FDA QSR, EU MDR, and combination product regulations. +… more
- ITG Brands (NC)
- …and nicotine products. The ideal candidate will bring deep expertise in FDA regulation, multi-state compliance, and regulatory litigation, with the ability to ... and nicotine products. Serve as a strategic legal advisor on FDA regulatory matters, including product submissions, labeling, marketing, enforcement, and reporting.… more
- Abbott (Plymouth, MN)
- …and submit medical device submissions to regulatory agencies + Interfaces directly with FDA and other regulatory agencies. + Acts as liaison between the Company and ... to appropriate personnel. + Reviews device labeling for compliance with FDA submissions and applicable regulations. + Supports the product release process… more
- Globus Medical, Inc. (Audubon, PA)
- …prototyping, development testing, design verification and validation, manufacturing, FDA approvals, product introduction and post introduction monitoring. This ... product development + Create and maintain project plans and FDA complaint Design history Files (DHF) for each project...Assist in the writing of regulatory applications to the FDA and other regulatory bodies. + Collaborate with the… more
- Abbott (Plymouth, MN)
- …and adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies to various international affiliates. + Maintains ... and timely manner to support Abbott customers. + May interface directly with FDA and other regulatory agencies if so directed. + Support all Company initiatives… more
- J&J Family of Companies (Spring House, PA)
- …prepare company personnel for interactions with Health Authorities (HAs). Ensure that responses to FDA questions are handled in a timely manner and in line with the ... is required. + Global regulatory experience with deep expertise in US FDA , EMA, and international regulations within scientific and commercial contexts is required.… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …insights for decision-making. Additionally, it manages regulatory communications such as FDA responses, drives continuous improvement across the quality system, and ... and collaborative decision making + Draft and coordinate responses to FDA warning letters, field action inquiries, and other regulatory correspondence. Ensure… more
- Compass Group, North America (Jacksonville, FL)
- …food safety and quality assurance programs to ensure compliance with USDA, FDA , FSIS, FSMA, customer, and corporate requirements. This role provides leadership in ... preventive controls, supply-chain controls, allergen controls, and prerequisite programs meet USDA, FDA , FSIS, FSMA, and corporate standards. + Serve as a subject… more