- 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
- 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
- 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
- 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
- Sumitomo Pharma (Little Rock, AR)
- …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 (Milford, DE)
- …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
- Kelly Services (South San Francisco, CA)
- …chromatographic methods. + Ensure analytical testing is conducted in full compliance with regulatory (ICH, FDA ) and internal quality requirements. + Provide ... + Manage production of registration batches in accordance with regulatory guidelines and quality standards. + Coordinate...tools (eg, HPLC-UV, LC-MS). + Comprehensive knowledge of ICH, FDA , and related regulatory requirements for method… more
- Astellas Pharma (Northbrook, IL)
- …with local and global stakeholders (eg, Product Development & Manufacturing, Regulatory Affairs, Quality Assurance, Business Partners). Responsible for ... teams. **Cross-Functional Collaboration:** + Partner with Product Development & Manufacturing, Quality Assurance and Regulatory Affairs teams to ensure alignment… more
- Kelly Services (Norcross, GA)
- …and enjoys driving strategy and collaboration across scientific, clinical, and quality teams. **Key Responsibilities** + Lead regulatory strategy development ... dossiers** . + Serve as the primary liaison with regulatory agencies, including the ** FDA , EMA, and...Class III device submissions** , **clinical studies** , and ** quality systems implementation** . **Technical & Leadership Skills:** +… more