- System One (Florham Park, NJ)
- …documents. + Conduct review of published submissions to ensure consistency and compliance with regulatory requirements. + Perform quality control checks on ... in the preparation and submission of electronic regulatory documents through the FDA and Health Canada Electronic Submission Gateways (ESG), as well as, prepare… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …testing and environmental monitoring (EM) in compliance with cGMP, USP, FDA , and internal quality standards. This position is in a fast-paced, ... implement continuous improvement opportunities to optimize workflows in the quality control microbiology laboratory. OVERALL JOB RESPONSIBILITIES: Operational Excellence:… more
- Bayer (Whippany, NJ)
- …and accurate implementation of new and revised labeling in accordance with FDA requirements and provides regulatory expertise and guidance for labeling operations ... and strategy to deliver high quality submission labeling. The position also facilitates strategic development...evaluates requests for new or revised labeling initiated by FDA or Bayer HealthCare Pharmaceuticals and manages action required… more
- Mentor Technical Group (PR)
- …Works (DTOP) regulations and safety standards. + Trains the Team on any necessary compliance and quality requirements related with the area or the business. + ... provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical… more
- Mentor Technical Group (Durham, NC)
- …packaging equipment. + Inspect packaging components (labels, cartons, inserts, etc.) for quality and compliance . + Complete and maintain accurate batch records, ... provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical… more
- embecta (Parsippany, NJ)
- …This role requires strong collaboration with senior leaders across Finance, Legal, Compliance , IT, Quality , and Operations to proactively identify risks, ... company's operations, with a focus on financial integrity, operational efficiency, regulatory compliance , and enterprise risk management. As a senior leader in a… more
- Hologic (Louisville, CO)
- …control processes within a Quality Management System (QMS). + Familiarity with FDA Quality System Regulations and ISO 13485 standards is a plus. + ... product changes, and play a critical role in maintaining compliance with quality and regulatory standards. If... standards. + Hands-on experience in industries regulated by FDA or ISO 13485 is highly preferred. + Familiarity… more
- Philips (Cambridge, MA)
- …C&R decisions, playing an important role in ensuring Sleep & Respiratory Care product quality and patient safety. **Your role:** + Will Manage the C&R team, driving ... regulatory inquiry responses, and reviews these responses to ensure compliance with C&R standards. + Leads meetings with senior...You've acquired a minimum of 8+ years' experience in FDA Regulated Post Market Surveillance (PMS), with a focus… more
- Kedplasma (Hot Springs, AR)
- …In this role, you'll support the Center Manager in overseeing daily operations, ensuring compliance , and fostering a culture of safety, quality , and care. As ... and preparing for staff changes, vacations, and absenteeism. + Identify and address quality or compliance issues proactively. + Monitor inventory levels and… more
- United Therapeutics (Houston, TX)
- …The Director, DPF Site Operations role is pivotal in maintaining regulatory compliance , upholding the highest quality standards, and driving operational ... ) and, as appropriate, ex/US regulatory agencies + Strong knowledge of cGMP compliance and Quality **Preferred Qualifications** + Master's degree in life… more