- 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
- 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
- PPL Corporation (Allentown, PA)
- …generations by helping to build and maintain strong, diverse communities today. Overview The Senior Project Manager position is the single point of ... project documents are complete, current, and stored appropriately. * Manages project budget. Determines appropriate revenue recognition , ensures timely 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
- ThermoFisher Scientific (Allentown, PA)
- **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** **Title: Sr Manager , Global Business Management CTD (Remote)** As ... internally adopt as "There is a Patient Waiting." **Discover Impactful Work:** **** The Sr Manager , Global Business Managment CTD will make an impact by… more
- Medtronic (Mounds View, MN)
- …launch lifesaving technologies, and be able to make a real difference. As a Sr . Design Engineering Manager , you will lead the Premarket Electrical and Firmware ... + Work closely with cross functional teams and quality peers to ensure project planning is complete end-to-end, for both pre-market and post-market activities. +… more
- Amazon (Austin, TX)
- …to the end customer. The Transparency team is seeking a skilled and experienced Sr . Program Manager who is excited about leading our supply chain traceability ... This is a global role that will include interaction with stakeholders across US, EU , CN, IN, JP and AU. Key job responsibilities - Identifying customer and business… 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
- Medtronic (Los Angeles, CA)
- …more connected, compassionate world. **A Day in the Life** Position Overview: The Senior Manager , Field Corrective Actions is responsible for leading and ... of global regulatory requirements (eg, FDA 21 CFR 806, EU MDR) for field actions/recalls + Strong project...computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions… more
- Northrop Grumman (Colorado Springs, CO)
- …Advanced Radar Capability (DARC) Program to support the customer's Early Use ( EU ) project objectives. The EU project for DARC enables USSPACECOM and the ... alongside the Northrop Grumman early use operations lead, and EU operators, will configure and operate the DARC computer...This role can be placed at Principal/Level 3 OR Sr . Principal/Level 4. **This position will be based out… 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
- PCI Pharma Services (Madison, WI)
- …building teams across our global network to pioneer and shape the future of PCI. The Senior QA Manager will work with other departments to ensure the quality of ... improvement. + Serve as QA representative to cross functional project teams such as process improvement. + Perform risk...production equipment and IQ/OQ/PQ + Knowledge of US and EU cGMP regulations and guidance + Experience using Risk… 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
- 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
- Abbott (Santa Clara, CA)
- …with diabetes from routine fingersticks. The Opportunity The primary function of a ** SENIOR CLINICAL EVALUATION SCIENTIST/ PROJECT MANAGER ** is to combine ... and therapeutic area knowledge to support Regulatory Affairs medical device submissions in the EU for CE Marking of new devices and maintaining of CE Mark for… 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
- PPL Corporation (Allentown, PA)
- …in organizations that support education, sustainability, and wellbeing. Overview The **Associate Project Manager ** is the single point of accountability for ... may also include support of project leaders, project managers, senior project managers...of work among direct reports and co-workers. Qualifications **_Associate Project Manager :_** 1. Bachelor's degree in Business,… more
