- J&J Family of Companies (Danvers, MA)
- …Manage initiatives for component replacements, redesigns, and system upgrades to extend product life and maintain regulatory compliance. + Regulatory ... searching for the best talent for an Engineering Project Manager - Console. Fueled by innovation at the intersection...+ Strong understanding of design controls, risk management, and regulatory requirements ( FDA , ISO). + Exceptional project… more
- Bristol Myers Squibb (Devens, MA)
- …teams to ensure validated state of cleaning processes. + Ensure compliance with regulatory guidelines ( FDA , EMA, cGMP, ICH) and internal SOPs. + Participate ... or audits. + Determines appropriate cleaning validation approaches based on regulatory requirements, risk assessments, and product /equipment needs. + Exercises… more
- Globus Medical, Inc. (Methuen, MA)
- …systems. + ** Product Development** + Collaborate with clinical experts, product managers, and regulatory teams to translate surgical workflow requirements ... **Position Summary:** We are seeking an experienced and innovative Manager to lead a multidisciplinary team of algorithm engineers...transfer from R&D to production under ISO 13485 and FDA guidelines. + ** Regulatory & Quality Compliance**… more
- Actalent (Hadley, MA)
- …through distillation. This role will serve as the site authority on quality systems, regulatory compliance. The QA Manager will oversee the implementation of the ... Job Title: QA Manager Department: Quality Position Summary: The Quality Assurance...Food Safety Plan, ensuring compliance with all applicable FDA regulations (21 CFR 111 and 117) and manage… more
- Takeda Pharmaceuticals (Lexington, MA)
- …sure that the HFE work is done in compliance with IEC 62366 & regulatory body (example, FDA ) expectations. Drive HF/UX initiatives in early stage, development, ... ensuring strategic and rigorous execution and timely delivery. **ACCOUNTABILITIES:** Senior Manager is responsible for Human Centered Design of Medical Devices and… more
- Astellas Pharma (Westborough, MA)
- …of qualification and validation procedures and practices in accordance with global regulatory bodies ( FDA , EMA, ICH, Japan guidance), Astellas policies and ... **Validation Manager ** Do you want to be part of...in compliance with user requirements, process parameters and global regulatory guidelines. The successful candidate will foster compliance across… more
- Medtronic (Boston, MA)
- …working under regulations of the FDA , notified bodies, and other regulatory agencies for successful commercial launches + Product launch experience working ... a Program Manager in our Robotics Surgical Technology (RST) Released Product Engineering (RPE) Project Management Office (PMO). In this pivotal role, you'll lead… more
- Takeda Pharmaceuticals (Boston, MA)
- …impacting combination products and device manufacturing. + Active engagement with Product Operations Lead, Quality, Regulatory , and External CMO Operations ... products and device manufacturing. + Strong understanding of design control and regulatory requirements ( FDA , EMA, ISO, USP) for combination products and… more
- Fujifilm (Boston, MA)
- **Position Overview** The CPQ Product Marketing Manager , Medical Informatics (MI), manages our go-to CPQ market strategy and workflows for the Synapse Enterprise ... into the North America and Global markets The CPQ Product Marketing Manager would ensure we are...with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO… more
- Medtronic (Newton, MA)
- …quality and reliability efforts for Cardiac Ablation Solutions products, ensuring compliance with regulatory standards such as FDA CFR, MDR, IEC 62304, and ISO ... extraordinary. Join Medtronic as a **Software Reliability Engineering Program Manager - Quality Core Team Member** and be at...hands-on time in the engineering lab and participation in product training as assigned. + Participate in software risk… more