- Bio-Techne (San Jose, CA)
- …The role requires understanding and implementing Federal, state, and local regulatory requirements, and supporting Cal/OSHA compliance programs at all California ... (OSHA, EPA) and California (Cal/OSHA, CalEPA, DTSC, SCAQMD/Bay Area AQMD) regulatory requirements. + Ensure California site compliance with: + Cal/OSHA Injury… more
- Fujifilm (Bothell, WA)
- …Sonosite's business exists or will expand. You will be part of a Regulatory Compliance team that conducts global due diligence for product compliance requirements, ... Our headquarters in Bothell, Washington, blends riverside charm with urban amenities, quality schools, and an ever-evolving downtown-all part of the vibrant Seattle… more
- Gilead Sciences, Inc. (Foster City, CA)
- … regulatory submissions (IND, NDA, etc.). + **Collaborate cross-functionally** with Regulatory , Quality , Clinical, and Manufacturing teams to align on ... and partners. + **Stay current with industry standards and regulatory expectations** , including FDA , EMA, ISO...industry standards and regulatory expectations** , including FDA , EMA, ISO 13485, ISO 14971, and cGMP. **Basic… more
- Fujifilm (Holly Springs, NC)
- …+ Drives MSAT collaboration with cross-functional teams across the network, including Regulatory , Quality , Supply Chain, Validation, and Program Management + As ... and cross-functional collaboration to drive continuous improvement and adherence to regulatory standards. The Director, Process Validation is crucial in enhancing… more
- J&J Family of Companies (New Brunswick, NJ)
- …and digital readiness. This role partners closely with regional MSAT, R&D, Quality , Regulatory , and Engineering teams to ensure consistent, compliant, and ... enable technology adoption to ensure robust, validated processes that meet regulatory expectations and deliver life-changing therapies to patients worldwide. **Role… more
- Astrix Technology (Monmouth County, NJ)
- …Ensure all documents are compliant with regulatory guidelines (ICH, EMA, FDA , etc.), internal SOPs, and quality standards. + Collaborate with ... cross-functional teams including drug safety, regulatory affairs, clinical development, and biostatistics. + Interpret and synthesize complex clinical and safety… more
- Cushman & Wakefield (Sunnyvale, CA)
- …will be responsible for coordinating the reporting and successful adherence to regulatory compliance & safety requirements in the client's portfolio of facilities. ... service delivery team and manage evidence and audit records for the regulatory compliance program. The Compliance Coordinator (CC) will coordinate with the… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …+ Ensure compliance with regulatory standards relevant to medical devices (eg, FDA , EMA, PMDA), quality systems/SOPs, data integrity and audit readiness. + ... they are completed on time, within budget, and in compliance with regulatory guidelines. + Design statistical analysis plans for clinical studies and observational… more
- Takeda Pharmaceuticals (Boston, MA)
- …cross-functionally to ensure scientific rigor and compliance with regulatory standards in all decision-making processes. **Accountabilities:** **A Senior ... to optimize R&D business impact in terms of costs, quality , and timeliness + Be accountable for growth and...+ Experience with at least one NDA/CTDs or other regulatory submissions + Experience representing Statistics function in interactions… more
- University of Washington (Seattle, WA)
- …IRG, CRBB, and the Radiation Safety Office (RSO) to meet all regulatory and compliance submissions involving editing of investigator initiated protocols and consent ... chart review studies by their medical students. Submit and maintain regulatory requirements of Industry Sponsored Trials. Submit cooperative group protocols and… more