- Globus Medical, Inc. (Methuen, MA)
- …technologies. + Support design transfer from R&D to production under ISO 13485 and FDA guidelines. + ** Regulatory & Quality Compliance** + Ensure adherence ... we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the… more
- J&J Family of Companies (Danvers, MA)
- …JTAG debuggers and laboratory test equipment such as oscilloscopes etc. + Knowledge of regulatory ( FDA , EPA) and quality processes. + Experience with ... signal processing) for precise system operation. + Ensure compliance with IEC 62304, FDA design controls, and other applicable regulatory standards. + Develop… more
- J&J Family of Companies (Danvers, MA)
- …JTAG debuggers and laboratory test equipment such as oscilloscopes etc. + Knowledge of regulatory ( FDA , EPA) and quality processes. + Experience with ... Software Architectures, Software Development Management, Software Engineering Practices, Software Quality Assurance (SQA), Systems Development Lifecycle (SDLC), Technologically Savvy… more
- Evident Scientific (Needham, MA)
- …and US Regulatory Compliance, leading end-to-end clinical programs and ensuring regulatory alignment with FDA and global standards. The position serves as ... clinical evidence synthesis. + Ensure alignment between clinical data, labeling, and regulatory claims. **Post-Market Compliance & Quality Interface** + Oversee… more
- Sumitomo Pharma (Boston, MA)
- …clinical regulatory strategies including management of IND and NDA submissions, FDA and other global regulatory interactions, as well as international ... the quality and scientific integrity of documents submitted to regulatory authorities + In collaboration with Commercial, Medical and Legal colleagues, conduct… more
- Dentsply Sirona (Waltham, MA)
- …device industry. + Experience with leading regulatory submissions and managing regulatory projects. + In-depth knowledge of FDA 510(k) and international ... communication skills. + Prior technical writing experience and proven track record with FDA and EU regulatory submissions. + Excellent interpersonal skills. +… more
- Dana-Farber Cancer Institute (Boston, MA)
- …documents for SRC and IRB review and approval. + Prepares and submits regulatory documentation that may include; IND/IDE applications, FDA annual reports, ... Office for Human Research Studies (OHRS), Office of Data Quality (ODQ) and the Clinical Trials Offices at the...regulatory agencies including the Food and Drug Administration ( FDA ), Office of Biotechnology Activities (OBA), etc. + Prepares,… more
- Dana-Farber Cancer Institute (Boston, MA)
- …Reg unit, the Regulatory Operations Manager (ROM) will oversee the CTIP Regulatory Unit, manage the development and quality control of protocol documents ... (along with Regulatory coordinators) is responsible for closely managing regulatory submissions and communication process, following a quality control… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …drug products and drug-device combination products. Ensure compliance with global regulations ( FDA , EMA, ICH, WHO) and anticipate regulatory changes impacting ... as CMC regulatory lead on global project teams (Pharmaceutical Development, Quality , Manufacturing, Global Regulatory Strategy). + Assess and provide … more
- Philips (Cambridge, MA)
- …right fit if:** + You've acquired a minimum of 7+ years' experience in Regulatory Affairs/Strategy within FDA regulated Medical Device environments. + You have ... The Principal Regulatory Affairs Specialist will develop and execute the...EUMDR tech files, and Pre-Sub notifications submitted to the FDA . + Your skills include familiarity with FDA… more