- 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
- Actalent (Fort Worth, TX)
- …of quality systems. Essential Skills + Medical device quality assurance + FDA regulatory affairs + Process and equipment validation + Documentation ... post-market surveillance, vigilance, and recall activities. + Liaise with regulatory agencies such as FDA , Notified Bodies,...+ Liaise with regulatory agencies such as FDA , Notified Bodies, and Health Canada. + Develop, implement,… more
- Sumitomo Pharma (Austin, TX)
- …+ Establish a working relationship with the Office of Prescription Drug Promotion (OPDP) at FDA . + Serve as internal regulatory expert on FDA regulations, ... a dynamic, highly motivated, and experienced individual for the position of **Director, Regulatory Advertising & Promotion** . The Director is part of the Global … more
- Fotona (Irving, TX)
- …building operational resilience in a dynamic, fast-paced environment. Key Leadership Responsibilities: Regulatory & FDA Compliance Strategy + Serve as the ... organizational lead for all FDA -related compliance activities and regulatory interactions. + Lead internal readiness for inspections and audits; manage FDA … more
- Abbott (Plano, TX)
- …determine if a medical device report needs to be filed with various global regulatory agencies (eg, FDA , European Competent Authorities) and sends reports within ... and work instructions are maintained; and support inspections by regulatory agencies (eg FDA , TUV) as requested. + The Product Surveillance Analyst must… more
- Actalent (Grand Prairie, TX)
- …international markets. Key Responsibilities + Ensure laboratory practices comply with FDA , Health Canada, and international regulatory requirements + Maintain ... within the OTC drugs OR Cosmetics *REQUIRED* + Strong understanding of regulatory frameworks, label review, FDA registration, and documentation standards +… more
- Danaher Corporation (Austin, TX)
- …related to Good Clinical Practice with hands on experience in dealing directly with FDA and other regulatory agencies + Proven track record of managing ... (ie, TMF, SOP compliance, training, etc.), interface to the FDA and notified bodies, clinical CAPA management, and IVDR...Clinical Affairs department, in addition to responses to global regulatory submissions following US and CE IVD approvals. +… more
- Actalent (Grand Prairie, TX)
- …in Grand Prairie, Texas! Description/Job Duties: + Ensure lab practices align with FDA , Health Canada, and international regulatory standards + Maintain and ... adverse event reporting, and compliance + Support audits and regulatory submissions for personal care and OTC products +...with QA and R&D to ensure product safety and regulatory readiness + Monitor regulatory updates and… 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
- Abbott (Plano, TX)
- … requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... in blueprint reading and experience with inspection sampling techniques. + Knowledge of FDA , GMP, and ISO 13485. + Good communication and computer skills, including… more