- Compass Group, North America (Boston, MA)
- …to Achieving Leadership in the Foodservice Industry-as a Quality Assurance Manager . We are seeking a safety-focused leader with an Ownership Mentality ... and Quality Assurance programs, ensuring strictly compliant operations that meet FDA , USDA, and corporate standards. **Key Responsibilities:** + Compliance &… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …company that will inspire you and empower you to shine? Join us as a Senior Manager of Statistics- CMC in our Cambridge, MA office. As a Senior Manager of ... skills. + Willingness and ability to self-educate in new areas. + Knowledge of FDA , EMA, and ICH regulations and industry standards applicable to the CMC is a… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- The Senior Manager , Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by ... of combined experience in pharmaceutical/medical device industry as a manager in Manufacturing, QA or QC role supporting GMP...requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and 211. + Experience… more
- Philips (Cambridge, MA)
- **Product Manager , Connectivity Hubs (Cambridge, MA)** As the upstream Product Manager for Medical Device Connectivity Hubs, you will assure the continued ... medical device products or medical device integration and working with the FDA and other global regulatory bodies. + Familiarity with healthcare technology solutions… more
- Danaher Corporation (Boston, MA)
- …System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Manager , Technical Sales is responsible for leading a ... and is part of the Commercial organization, as a manager for the Technical Sales team. Located in Fargo,...+ Drug Development sales cycle and regulatory approval framework ( FDA ) + cGMP manufacturing + Sales Coaching and Value… more
- Insight Global (Westborough, MA)
- Job Description We are seeking a hands-on Technical Project Manager to support Engineering Operations by actively managing and contributing to work across R&D ... and verbal communication skills. Experience with SaMD / medical device regulations ( FDA , ISO 13485, IEC 62304, IEC 82304-1). Familiarity with design validation,… more
- Fresenius Medical Center (Lawrence, MA)
- **PURPOSE AND SCOPE:** The ** Manager , HCP Marketing** is responsible for developing and executing clinically focused marketing strategies to support the education, ... skills with keen attention to accuracy and compliance. + Understanding of FDA promotional guidelines and medical-legal review processes. + Analytical mindset and… more
- Wolters Kluwer (Waltham, MA)
- **Regulatory Initiatives Product Manager ** Wolters Kluwer is a global leader in professional information and software solutions, trusted by clinicians and healthcare ... health. + Some understanding of global healthcare regulations and frameworks ( FDA , EU MDR/IVDR, HIPAA, GDPR). + Experience with AI/ML-driven products or… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Job Summary** The Senior Manager of Global Quality Management (GQM) supports the execution of clinical quality activities to ensure compliance with Good Clinical ... + Prior collaboration with CROs and external vendors. + Exposure to FDA or other health authority inspections. **Competencies** **Accountability for Results -** Stay… more
- Edwards Lifesciences (Boston, MA)
- …lives. Join us and be part of our inspiring journey. The Senior Manager , Medical Writing oversees medical writing projects and team operations in compliance with ... and performance oversight. + Expertise in medical writing processes, regulatory requirements ( FDA , EU MDR), GCP, and ICH guidelines. + Advanced knowledge of… more