- Norstella (Boston, MA)
- …and biotech companies around the world, along with regulators like the FDA , and payers. By providing critical proprietary data supporting AI-driven workflows, ... Success Renewals Specialist works in collaboration with the Client Success Operations Manager and Client Success team members in the overall responsibility for MMIT… more
- Medtronic (Newton, MA)
- …**Preferred Qualifications** + Knowledge of Medical Product verification, IEC-62304 and FDA guidance in a technical discipline, preferably software related + Strong ... interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements… more
- North Coast Seafoods (Chatham, MA)
- …are made accurately and on time. This position reports to the General Manager . Duties & Responsibilities + Deliver product to specific locations to scheduled route ... the following motions: bending, twisting, squatting and reaching + Exposure to FDA approved cleaning chemicals + Exposure to temperatures: <32 degrees Fahrenheit +… more
- Fujifilm (Boston, MA)
- …This position reports directly to the Zone Sales Director or Regional Manager . **Company Overview** At FUJIFILM Healthcare Americas Corporation, we're on a mission ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- Fujifilm (Boston, MA)
- …to cross sell additional products and options. + Work Hospital Relations Manager , National and Government Accounts to develop relationships and implement hospital ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- Fresenius Medical Center (Lawrence, MA)
- …for assistance with complex problems that may arise. + Escalate issues to supervisor/ manager as necessary. + Review and comply with the Code of Business Conduct ... with proficiency in Microsoft Office applications. + Understand and apply FDA Guidelines, standards (ISO/AAMI/USP), and Design/Pharma Control Concepts. + Strong oral… more
- Parexel (Boston, MA)
- …applicable. + Ensure document structure, content, and style adheres to FDA /EMA or other appropriate regulatory guidelines, and comply with departmental, corporate ... content review. **Document Project Management** + Act in the capacity of project manager /lead for medical writing projects, which may entail serving as the primary… more
- Parexel (Boston, MA)
- …Management and Monitoring (DSMM) + Partners with SCP and Country Study Operations Manager (SOM) + When required Partners with other Study Team members (eg Clinician, ... + Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration ( FDA ) and local country regulations + Must be fluent in English and in… more
- Sanofi Group (Cambridge, MA)
- …Briefing regulatory documents, Common Technical Document for submission to regulatory bodies ( FDA , EMA, PMDA etc ) and answers to questions from health authorities. ... Collaborate on key medical and clinical questions with the Global feasibility manager to prepare and interpret feasibility and competitive intelligence results +… more
- Takeda Pharmaceuticals (Lexington, MA)
- …manufacturing associate candidates as needed. You will report into the Manufacturing Manager . **How you will contribute:** + Assign appropriate curriculum to new ... etc. + Knowledge of cGMP's and applicable agency regulations (such as the FDA , EMA) to ensure inspection readiness of department **More about us:** At Takeda,… more