- Actalent (Auburndale, MA)
- Job Title: Engineering Project Manager Job Description We are seeking an experienced Project Manager to lead the development of a Surgical Robot. This ... and contracted companies. + Formulate and gain approval for overall project plans in consultation with program managers, senior management, and stakeholders.… more
- Tecomet (Woburn, MA)
- **TITLE** : Quality Assurance & Regulatory Affairs Manager **Department:** Quality Assurance / Regulatory Affairs **Classification:** Exempt **Reports To:** Senior ... improve quality systems/programs, reduce quality costs and maintain compliance within FDA and ISO regulations. This is accomplished by maintaining Tecomet principles… more
- Sumitomo Pharma (Boston, MA)
- …a dynamic, highly motivated, and experienced individual for the position of Senior Manager , Regulatory Operations, For assigned projects, the Senior Manager of ... publishing, distribution, and archiving of health authority submissions. The Senior Manager will oversee the activities of external publishing staff contracted to… more
- Takeda Pharmaceuticals (Boston, MA)
- …company to inspire you and empower you to shine? Join us as a Manager , Global Trade Compliance based in Cambridge/Lexington, MA reporting to the Senior Director - ... contributor to our inspiring, bold mission. **_GOALS:_** The Global Trade Compliance Manager will ensure that Clinical and R&D imports and exports are conducted… more
- Abbott (Westford, MA)
- …+ Provide leadership to engineering and facilities staff regarding project prioritization, process validations, problem solving, and continuous improvement ... strategies for long range product cost and margin improvements. + Provide project management for larger strategic initiatives. + Implement and manage resource… more
- Medtronic (Boston, MA)
- …Minneapolis, MN, or Boston, MA. Join Medtronic as a Commercial Development Program Manager in our Surgical group - Post-Market Project Management Office (PMO). ... tests with competitors and kitting projects. + Manage projects with well-defined project plans and delivery methodologies. + Establish with the project … more
- ICON Clinical Research (Boston, MA)
- As a CLinical Trial Manager you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. **What ... studies, in compliance to all applicable regulations (like ISO, GCP and FDA ) and Philips procedures, working under limited supervision. + Ensures strict adherence… more
- Takeda Pharmaceuticals (Boston, MA)
- …job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** : Senior Manager , Programming **POSITION DESCRIPTION** : Takeda Development Center Americas, Inc. ... is seeking a Senior Manager , Programming with the following duties: Lead clinical studies,...ADaM datasets as per CDISC IG (Implementation guide) and FDA TCG (Technical conformance Guide); contribute to process improvement… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. Works ... the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. - Works… more
- Medtronic (Boston, MA)
- …Ensure all software verification activities adhere to relevant medical device regulations (eg, FDA 21 CFR Part 820, ISO 13485, IEC 62304) and internal quality ... of software components. + Participate in design reviews, risk assessments, and project planning to provide early feedback on software design and testability. +… more