- Integra LifeSciences (Princeton, NJ)
- …of care. Under direct supervision of Director, Quality Reliability Microbiology, the Sr . Manager , Microbiology Reliability - Tissue Technology will have ... of junior-level technical employees is preferred. Responsibilities associated with this Sr . Manager , Microbiology Reliability - Tissue Technology (TT) are… more
- Integra LifeSciences (Princeton, NJ)
- …to advance patient outcomes and set new standards of care. **SUMMARY** The Senior Quality Compliance Manager will lead, coordinate and perform corporate audits ... while driving audits forward consistently and on time, as well as project and time management. Their mix of objectivity, experience, qualifications, technical… more
- Olympus Corporation of the Americas (Westborough, MA)
- …processes to support Olympus' digital transformation journey. This position supports the Global Senior Manager to plan and direct the OSTA Core Regulatory ... with applicable global regulations (eg, IEC 82340-1, IEC 81001-5-1, GDPR, HIPAA, EU AI Act, Cybersecurity regulations, and relevant consumer protection laws). +… more
- Olympus Corporation of the Americas (Westborough, MA)
- …about Life at Olympus: https://www.olympusamerica.com/careers . **Job Description** The Sr . Regulatory Affairs (RA) Specialist II Digital Health supports regulatory ... and standards (eg, IEC 82304-1, IEC 81001-5-1, GDPR, HIPAA, EU AI Act, cybersecurity and consumer protection laws). +...+ Ability to work independently while contributing to cross-functional project teams. + Passion to challenge the status quo… more
- BeOne Medicines (Pennington, NJ)
- …effective day to day operations of the Physicochemistry laboratory. This position reports to the Senior Manager QC and is located full time at the Hopewell, NJ ... and release of materials, intermediates and finished products under FDA/ EU regulations, applicable International Regulations, BeOne processes and procedures.… more
- Olympus Corporation of the Americas (Westborough, MA)
- …creating submission materials for various regulatory domains including FDA, PMDA, and EU -MDR. **Job Duties** + Advise SW development teams on Software development ... rapid product delivery while maintaining compliance and quality. + Provide project management oversight for QMS integration, Quality plans, process updates, and… more
- Exelon (Washington, DC)
- …storms or other energy delivery emergencies. **Primary Duties** + Responsible for project Construction, ensuring all work is performed to standard, within budget, on ... relationships. Address customer concerns promptly to maintain positive connections with all EU stakeholders. (30%) + Manage the tasks being performed by internal and… more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- **Job Description Summary** The Sr . Manager , Clinical Quality serves as a key leader within the Medical Affairs organization, responsible for overseeing a team ... a **maker of possible** with us. **Job Summary:** The Sr . Manager , Clinical Quality serves as a...oversight for the Clinical Quality team, including resource planning, project timeline adherence, and compliance with applicable regulations and… more
- Taiho Oncology (Princeton, NJ)
- …Hybrid Employee Value Proposition: Join our dynamic and expanding mid-size company as a Sr . Manager , Regulatory Affairs Strategy. In this role, you will support ... developmental, life cycle, and post-approval projects in the US, EU , Canada, and beyond. You will work closely with...activities and clinical study teams. + Provide updates to project /study teams on the regulatory activities. + Conduct risk… more
- Hologic (Newark, DE)
- Sr Manager , Quality Assurance Newark, DE,...a regulated environment? At Hologic, we are seeking a ** Senior Manager , Quality Assurance** to lead the ... Expertise in FDA 21 CFR Part 820, ISO 13485:2016, EU MDR 2017/745, and other global regulatory standards. +...effectively across all levels of the organization. + Strong project management skills to lead quality initiatives, manage resources,… more
- PPL Corporation (Allentown, PA)
- …by helping to build and maintain strong, diverse communities today. Overview The Senior Manager Interconnection Affairs is responsible for the daily management ... and works closely with the Director of Asset Management, Manager of Project Development, Manager ...not limited to scope, schedule and budget between PPL EU and generator owners/developers. * Oversee transmission and distribution… more
- Kratos Defense & Security Solutions, Inc. (Fort Walton Beach, FL)
- …proposals for existing contracts + Draft and submit grant applications and formal project proposals + Conduct both short- and long-range planning to achieve program ... departments to meet program requirements + Maintain ongoing communication with senior leadership regarding program issues, milestones, and achievements + Adhere to… more
- Newell Brands (Huntersville, NC)
- …collaborative environment where you can be your best, every day. The Regulatory Senior Manager is responsible for leading global regulatory compliance and ... manages complex regulatory projects, and drives continuous improvement in compliance processes. The Senior Manager will lead and develop a team of regulatory… more
- Bristol Myers Squibb (Indianapolis, IN)
- …aims to be the global leader in radiopharmaceuticals. **Summary** The Senior Specialist, External Manufacturing Quality Assurance is responsible for quality ... standards, procedures and global current Good Manufacturing Practice (cGMP). The Senior Specialist provides Quality support and oversight for CMO operations and… more
- Medtronic (Minneapolis, MN)
- …direct experience submitting regulatory submissions for both the Americas and the EU . **Role Overview** The Senior Regulatory Affairs Specialist develops ... in a more connected, compassionate world. **A Day in the Life** ** SENIOR REGULATORY AFFAIRS SPECIALIST** In collaboration with leading clinicians, researchers, and… more
- Danaher Corporation (San Diego, CA)
- …System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Technical Writer for Leica Biosystems creates ... current with strict regulatory and business requirements. This position reports to the Manager , Technical Writing & Training, and is an onsite role based in the… more
- Taiho Oncology (Princeton, NJ)
- …off on clinical documents related to clinical studies as outlined by the manager . + Attend study site initiation visits (SIV) and provides therapeutic area, ... for the study conduct and operational risks. Represent the molecule at senior management governance meetings. + Co-responsible with Clinical Development, Project … more
- Cardinal Health (Waukegan, IL)
- …modified product development projects to establish and integrate regulatory strategy into project activities. + Lead, under direction of manager , the ... Cardinal Health is seeking a Senior Regulatory Affairs Specialist to support the Medical...of global product registrations with a focus on 510(k), EU Technical Documents, and International STEDs. + Collaborate with… more
- Ascendis Pharma (Palo Alto, CA)
- …a dynamic workplace for employees to grow and develop their skills. The Regulatory Project Manager will be an integral part of Global Regulatory Affairs, ... providing project management leadership to key global regulatory submissions across...global regulatory strategies for assigned therapeutic areas in US, EU , UK, CAN, and ROW, and ensure planning and… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Senior Manager , Global Regulatory Labeling Strategy where you will be responsible ... medium complexity and updates to TLP, CCDS, USPI and EU SmPC. You will also be responsible for providing...for other medium and/or high complexity products. Interface with Senior Management Cross-Functional Team (GLOC) + Coordinates the process… more
