- Dow (Houston, TX)
- At a glance Position: FDA Product Regulatory Manager Primary Location:Midland (MI, USA), Michigan, United States of America Additional Locations: Freeport (TX, ... Type:Regular Workplace Type:Remote or Hybrid or Onsite Apply Now (https://dow.wd1.myworkdayjobs.com/ExternalCareers/job/Midland-MI-USA/ FDA -Product- Regulatory -Manager\_R2060938/apply) Return to Job Finder At Dow,… more
- TE Connectivity (Wilsonville, OR)
- …parties regarding the QMS (eg, customer, assessor, FDA & other regulatory entities); leading quality improvement initiatives in support of customer and ... non-conforming product and MRB resolution. * Ensures compliance with FDA QSR, ISO, MDD and other applicable requirements. *...* Provides sales and marketing support in explaining the quality system and regulatory compliance capability to… more
- Actalent (Cincinnati, OH)
- …to support investigations and continuous improvement initiatives. + Ensure compliance with FDA regulatory requirements and internal quality standards. ... Job Title: Quality Control (QC) Analyst - Pharmaceutical Industry Location:...a plus. + Strong understanding of cGMP, GLP, and FDA regulatory requirements. + Excellent documentation, organizational,… more
- Actalent (Fort Worth, TX)
- …ensure consistent implementation of quality systems. Essential Skills + Medical device quality assurance + FDA regulatory affairs + Process and equipment ... Job Title: Quality / Regulatory Manager Job Description The Head...post-market surveillance, vigilance, and recall activities. + Liaise with regulatory agencies such as FDA , Notified Bodies,… more
- Tecomet (Woburn, MA)
- **TITLE** : Quality Assurance & Regulatory Affairs Manager **Department:** Quality Assurance / Regulatory Affairs **Classification:** Exempt **Reports ... To:** Senior Director of Quality Assurance and Regulatory Affairs **Date:** XX...create, monitor and improve quality systems/programs, reduce quality costs and maintain compliance within FDA … more
- Stryker (Redmond, WA)
- …and risk assessments + Ensure compliance with internal quality procedures and regulatory requirements, including FDA Quality System Regulations (QSR's) + ... **Customer Quality Engineer** Stryker is seeking a **Customer Quality Engineer** to join our team in Redmond, WA. This hybrid role supports continuous… 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)
- …reports per US FDA regulations. The Associate Director, US Product CMC Regulatory Affairs acts as primary internal contact for all US regulatory relevant ... of original and/or supplemental applications and post marketing reports per US FDA regulations. Responsible contact for US regulatory relevant topics, and… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …involving FARs and recalls. Essential Functions: + Will be the contact person for the FDA and other regulatory agencies in regard to Field Alerts responses and ... The Manager, Field Alert & Recall Compliance is responsible for overseeing regulatory activities related to Field Alert Reports (FARs), product recalls, and market… 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