- Globus Medical, Inc. (Audubon, PA)
- …to ensure timely completion of tasks while remaining in full compliance with Globus quality system and other applicable regulatory bodies . Designs and develops ... sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our...and market plans . Assists in the writing of regulatory applications to the FDA and other… more
- Mount Sinai Health System (New York, NY)
- …to support enrollment and data quality goals. ** Regulatory & Quality Management** + Ensure compliance with FDA , ICH/GCP, IRB, and institutional standards ... for Interventional Cardiovascular Research & Clinical Trials. This role ensures high- quality , efficient study execution consistent with institutional, FDA , and… more
- Lilly (Indianapolis, IN)
- …and reduce inspection errors. **Compliance & Documentation** : + Ensure compliance with FDA and any other global applicable regulatory standards by keeping ... across a global manufacturing network to ensure the highest quality standards. Your team will provide expert guidance on...and equipment specific to parenteral products. + Familiarity with regulatory guidelines ( FDA , EMA, ICH) and experience… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …assessments, method development, and validation activities, supporting compliance with global regulatory requirements and internal quality standards. The role ... processes. + Support packaging integrity and EO residual testing strategies. + ** Regulatory & Quality Compliance:** + Author and review microbiology-related… more
- GRAIL (Durham, NC)
- … submission materials as required. + Maintain high standards of scientific rigor, quality , and regulatory compliance in all process integration activities. + ... process optimization experience, and a thorough understanding of clinical laboratory regulatory frameworks. This position is **onsite full-time** , with **5 days… more
- Edwards Lifesciences (Irvine, CA)
- …effectively with cross-functional partners including Delivery System R&D, Manufacturing, Quality Engineering, Regulatory Affairs, and Clinical Development to ... R&D Engineering team, you will work closely with our Quality and Manufacturing teams to develop the latest tools...skills including proficiency with Microsoft Word + Familiarity with regulatory standards (ISO, FDA ) and design control… more
- Valent BioSciences (Osage, IA)
- …manages customer complaint and Material Review Board (MRB) programs, and ensures adherence to regulatory requirements including EPA FIFRA GLP and FDA 21 CFR Part ... Compliance Specialists to ensure alignment with company standards and regulatory expectations. + Act as Quality Assurance...to ensure compliance with ISO/IEC 17025, ISO 9001, and FDA 21 CFR Part 11. + Partner with IT… more
- J&J Family of Companies (Danvers, MA)
- …production equipment. + Ensure calibration traceability and compliance with regulatory and quality systems (eg, ISO 13485, FDA QSR 21 CFR Part 820). ... as needed. **Performance Reporting** + Ensure calibration traceability and compliance with regulatory and quality systems (eg, ISO 13485, FDA QSR 21 CFR Part… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …equipment performance, facility layout, and quality of product. Maintain a quality presence to ensure compliance with all regulatory requirements. Maintain ... performed for out-of-specification results or out-of-procedure events. Participate in regulatory and internal inspections/audits including providing written responses as… more
- Terumo Medical Corporation (Elkton, MD)
- …design control, quality , and company regulations and national and international regulatory body requirements. This activity includes, but is not limited to, the ... development prototype evaluations, or could be submitted to the FDA to support new product clearance or claims. 10....development of global Medical Devices in accordance with global regulatory and quality standards and requirements. o… more