- Stryker (Mahwah, NJ)
- …You will work across multiple Stryker sites and collaborate with R&D, Quality , Regulatory , and Operations to ensure manufacturability, scalability, compliance, ... Implement and promote lean manufacturing and Six Sigma methodologies. + Collaborate with Quality , Regulatory , and Advanced Technology to ensure compliance with … more
- Hologic (Newark, DE)
- …Excellent project management, communication, and interpersonal skills. + In-depth knowledge of FDA Quality System Regulation (Design Control), ISO 13485, ISO ... our market-leading devices continue to meet the highest standards of quality , reliability, and safety. As the **Sr. Manager, R&D, Sustaining Engineering**… more
- Abbott (Alameda, CA)
- …design experience preferred + Detailed experience with medical device development processes and FDA 510K and PMA regulatory requirement and process is desirable. ... development, verification, and validation; responsible for on-time delivery of high- quality embedded software biowearable products that meet budgetary objectives. +… more
- NTT DATA North America (Pittsburgh, PA)
- …executive visibility. Enforce compliance with PMO governance, documentation standards, and regulatory requirements (eg, FDA CSV). Drive continuous improvement by ... Experienced in delivering projects in regulated environments, ensuring compliance with FDA Computer Systems Validation (CSV) and quality standards. Led… more
- ManpowerGroup (Zeeland, MI)
- …completed on time, within budget, and in compliance with food safety, quality , and cGMP/ FDA standards. The Project Engineer collaborates closely with ... development, and execution of capital projects while ensuring compliance with regulatory , safety, environmental, and industry standards. + Provide technical guidance… more
- Abbott (Milpitas, CA)
- …highly desirable + Detailed experience with medical device development processes and FDA 510K and PMA regulatory requirement **Preferred Qualifications** + Good ... the development, verification, ensuring timely delivery and adherence to FDA -compliant design control procedures. They provide technical leadership, mentoring, and… more
- Abbott (Alameda, CA)
- …is highly desirable + Detailed experience with medical device development processes and FDA 510K and PMA regulatory requirement + Preferred team leadership ... the development, verification, ensuring timely delivery and adherence to FDA -compliant design control procedures. They provide technical leadership, mentoring, and… more
- Cytel (Charleston, WV)
- …and associates across Cytel. + Maintain strong engagement with senior client leadership, regulatory agencies ( FDA /EMA), and key opinion leaders to support and ... junior colleagues, and driving high-impact consulting engagements. + Experience interacting with regulatory agencies ( FDA /EMA) and key opinion leaders to shape… more
- Bristol Myers Squibb (Indianapolis, IN)
- … regulatory filing. . Review and author CMC sections for IND/NDA for FDA submissions, and support regulatory filing in other jurisdictions, eg EMA, Health ... Canada, etc. . Collaborate cross-functionally with Regulatory , Quality , Supply Chain, Clinical, and R&D teams to ensure alignment with corporate goals . Up to… more
- ThermoFisher Scientific (South San Francisco, CA)
- …support of the business units. **Discover Impactful Work:** Your work will impact the quality of the FDA submissions and help secure the necessary approvals for ... Description** **Location/Division Specific Information** This position is part of the Regulatory and Clinical Affairs organization which ensures that the internal… more