- Dentsply Sirona (Waltham, MA)
- …role manages and submits 510ks for the products and manages communications with FDA including pre-subs. The individual will also be responsible for mentoring and ... technical files for CE marking. + Manages communications with FDA and EU notified bodies on behalf of the...EU notified bodies on behalf of the company for FDA pre submissions, FDA 510(k) submissions and… more
- Dana-Farber Cancer Institute (Boston, MA)
- …unit will support interventional studies to the IRB as well as assist with FDA submissions and IND management. Reporting to the CTIP Associate Director for the ... Pediatric unit, the Regulatory Operations Manager (ROM) will oversee the CTIP Regulatory Unit, manage...appropriate regulatory agencies including the Food and Drug Administration ( FDA ), Office of Biotechnology Activities (OBA) + Support the… more
- Mitsubishi Chemical Group (Wilmington, MA)
- …Division **Job Description:** **About the Role** We are seeking an experienced Quality Manager to lead and continuously improve our Quality Management System in a ... regulatory compliance, and operational excellence across the site. The Quality Manager oversees daily quality operations, including product and raw material release,… more
- J&J Family of Companies (Danvers, MA)
- …supervisory or manager -level role + Familiarity with ISO 13485 and FDA QSR/21 CFR Part 820; experience with calibration standards and regulatory records ... at https://www.jnj.com/medtech **We are searching for the best talent for Manager , Production Equipment Services** **Purpose:** This role leads the maintenance,… more
- Hologic (Marlborough, MA)
- Manager , Field Actions Newark, DE, United States Marlborough, MA, United States Are you ready to make a meaningful impact on global healthcare compliance and patient ... At Hologic, we are seeking an experienced **Field Actions Manager ** to lead the coordination and execution of global...21 CFR Part 806 (Reports of Corrections and Removals), FDA Quality System Regulations, ISO 13485:2016, and EU Medical… more
- Oracle (Boston, MA)
- …EHR and AI-enabled medical device platforms. As a Clinical Product Manager (Medical Device Focus), you'll provide clinical insight into product design, ... Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring… more
- Oracle (Boston, MA)
- …EHR and AI-enabled medical device platforms. As a Clinical Product Manager (Medical Device Focus), you'll provide clinical insight into product design, ... Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring… more
- Bristol Myers Squibb (Devens, MA)
- …no better place than here at BMS with our Cell Therapy team. The ** Manager , Global Trade Operations, Cell Therapy** will ensure the import and export compliance for ... to export controls, denied parties, and embargoed countries. The Manager will also assist with global export compliance in...errors. + Provide clearance information to the designated brokers, FDA and other government agencies for entries. + Relay… more
- North Coast Seafoods (New Bedford, MA)
- The Maintenance & Facilities Manager at North Coast will be responsible for managing and leading our team of maintenance personnel to ensure production equipment & ... operating within the seafood manufacturing plant. The Maintenance & Facilities Manager shall ensure successful preventive maintenance and breakdown maintenance of… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …products and drug-device combination products. Ensure compliance with global regulations ( FDA , EMA, ICH, WHO) and anticipate regulatory changes impacting CMC ... for investigational, marketed product submissions (IND/IMPD/NDA/MAA/DMF, post-approval supplements) for FDA and equivalent submissions for Europe and Canada. +… more