- Globus Medical, Inc. (Methuen, MA)
- …technologies. + Support design transfer from R&D to production under ISO 13485 and FDA guidelines. + ** Regulatory & Quality Compliance** + Ensure adherence ... we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the… more
- Unilever (Austin, TX)
- …such as the FDA and FTC. In addition to managing day-to-day quality and regulatory functions, this leadership role requires strategic oversight and close ... be part of it. **JOB SUMMARY** The Senior Director, Quality Assurance and Regulatory Affairs will lead...internal audits and support third-party, FDA , and regulatory inspections. + Generate and analyze quality … more
- Boar's Head Brand/Frank Brunckhorst Co., LLC (Holland, MI)
- …Duties and Responsibilities + Assist in troubleshooting with USDA-FSIS and FDA regulatory issues and food safety or quality deviations. + Provide support to ... Delicatessen Services Co., LLC Overview:Oversee all the manufacturing food safety and quality as well as continuous improvement initiative. Initiates or consults on… more
- J&J Family of Companies (Danvers, MA)
- …JTAG debuggers and laboratory test equipment such as oscilloscopes etc. + Knowledge of regulatory ( FDA , EPA) and quality processes. + Experience with ... signal processing) for precise system operation. + Ensure compliance with IEC 62304, FDA design controls, and other applicable regulatory standards. + Develop… more
- WuXi AppTec (Middletown, DE)
- …preparation and maintenance of User Requirements Specifications. + Ensuring compliance with regulatory requirements ( FDA , EMA, cGMP), quality standards, and ... and powder packaging. + Collaborating with cross-functional teams, including R&D, Quality Assurance, Production, and Regulatory Affairs. + Experience in… more
- ThermoFisher Scientific (Fremont, CA)
- …and operational excellence experience at scale * Strong working knowledge of cGMP, FDA , and other relevant quality / regulatory requirements . Exposure to ... future leaders . Advanced understanding and ability to adhere to established quality standards and regulatory compliance requirements for medical device or… more
- J&J Family of Companies (Athens, GA)
- …to be directed to your accommodation resource. **Required Skills:** FDA Regulatory Requirements, Good Manufacturing Practices (GMP), Quality Assurance (QA), ... with quality assurance standards. Stay informed of industry trends, regulatory changes, and advancements in quality management practices. Assists in… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …for decision-making. Additionally, it manages regulatory communications such as FDA responses, drives continuous improvement across the quality system, and ... **Job Description Summary** The Quality Systems and Regulatory Staff Lead...FDA warning letters, field action inquiries, and other regulatory correspondence. Ensure timely and accurate updates on mitigation… more
- J&J Family of Companies (Danvers, MA)
- …JTAG debuggers and laboratory test equipment such as oscilloscopes etc. + Knowledge of regulatory ( FDA , EPA) and quality processes. + Experience with ... Software Architectures, Software Development Management, Software Engineering Practices, Software Quality Assurance (SQA), Systems Development Lifecycle (SDLC), Technologically Savvy… more
- BD (Becton, Dickinson and Company) (El Paso, TX)
- …Final Product Release, Quality Engineering, Customer Complaint Investigation and Supplier Quality . + Knowledge of FDA regulatory requirements (QSRs - ... Supplier Quality while maintaining full compliance with FDA Quality System Regulations (21 CFR Part...21 CFR Part 820) + Knowledge of International regulatory requirements (ISO 13845, MHRA GMPs, etc.) + Responsible… more
- Kemin Industries (Des Moines, IA)
- Overview Kemin Health is hiring an Associate Director of Regulatory /Scientific Affairs and Quality ! In this role, you will be responsible for leading the ... business units' regulatory affairs (RA) and quality assurance (QA)...regulatory entities, including, but not limited to US FDA , EFSA, Health Canada, ANVISA, etc. + Responsible for… more
- Evident Scientific (Needham, MA)
- …and US Regulatory Compliance, leading end-to-end clinical programs and ensuring regulatory alignment with FDA and global standards. The position serves as ... clinical evidence synthesis. + Ensure alignment between clinical data, labeling, and regulatory claims. **Post-Market Compliance & Quality Interface** + Oversee… more
- Schwan's Company (Minneapolis, MN)
- …it's a seat at the table! Are you a seasoned food safety and quality compliance leader passionate about driving regulatory excellence across the supply chain? ... and Good Manufacturing Practices, driving continuous improvement in food safety and quality standards. Subject Matter Expert on regulatory programs: Serve as… more
- Globus Medical, Inc. (Audubon, PA)
- … Regulatory team in preparing and filing 510(k), IDE, PMA submissions, FDA reports, all international regulatory submissions and registrations, responds to ... sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our...conformance to 21 CFR regulations. + Assists with other regulatory matters as requested. + Attends FDA … more
- Sumitomo Pharma (Montgomery, AL)
- …clinical regulatory strategies including management of IND and NDA submissions, FDA and other global regulatory interactions, as well as international ... the quality and scientific integrity of documents submitted to regulatory authorities + In collaboration with Commercial, Medical and Legal colleagues, conduct… more
- Dentsply Sirona (Waltham, MA)
- …device industry. + Experience with leading regulatory submissions and managing regulatory projects. + In-depth knowledge of FDA 510(k) and international ... communication skills. + Prior technical writing experience and proven track record with FDA and EU regulatory submissions. + Excellent interpersonal skills. +… more
- Integra LifeSciences (Princeton, NJ)
- …Reports, 30 Day Notices, and 180 Day Submissions in accordance with US FDA requirements. + Interact with Regulatory Body personnel with minimal supervision. ... complex Change Engineering Requests, Document Change Requests, Variances, and other Quality System Documentation that requires regulatory review and approval… 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
- Conagra Brands (Omaha, NE)
- **Job Summary** Reporting to the Manager of Food Safety, Quality & Regulatory Affairs, you will implement programs within the Packaging Supplier FSQRA group ... execution of processes and procedures and lead daily activities related to food safety, quality , and regulatory compliance. **Your Impact** + You will gather and… more
- University of North Carolina- Chapel Hill (Chapel Hill, NC)
- …work location is subject to change based on the unit's business needs. The Quality Assurance & Regulatory Specialist will be responsible for supporting Research ... implementing, and maintaining quality assurance processes. The Quality Assurance & Regulatory Specialist plays a...Practice ( GCP ), Food and Drug Administration ( FDA ) regulations and International Conference on Harmonization (… more