- 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, ... concepts + Experience in using research tools and databases (eg, ClinicalTrials.gov, EMA, FDA , SEC filings) + High proficiency in MS Office Suite (Excel, Word,… more
- Medtronic (Boston, MA)
- …mitigation strategies in accordance with IEC 81001-5-1, ISO 14971, and FDA premarket cybersecurity guidance. + **Security Architecture & Design** - Collaborate ... secure architecture in embedded and connected device ecosystems + Familiarity with FDA and MDR cybersecurity submission requirements + Knowledge of secure coding… more
- Globus Medical, Inc. (Methuen, MA)
- …+ Support design transfer from R&D to production under ISO 13485 and FDA guidelines. + **Innovation & Continuous Improvement** + Identify emerging technologies and ... familiarity with robotics, sensors, and real-time control systems are preferred + Knowledge of FDA 21 CFR Part 11, IEC 60601, and HIPAA compliance. + Knowledge of… more
- J&J Family of Companies (Danvers, MA)
- …and standards (for example, IEC 60601-1 _IEC_ 60601-1 and applicable FDA guidance). + Experience with communication interfaces and embedded systems (UART, ... + Experience supporting regulatory submissions and preparing verification packages for FDA /Notified Body review. + Experience with complex fluidic systems and… more
- GRAIL (Boston, MA)
- …author regulatory plans and activities to optimally position GRAIL products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team ... degree may count toward years of experience. + Direct experience with FDA regulatory submissions required. + Experience with regulatory submissions in the EU,… more
- Actalent (Boston, MA)
- …and excellent patient care, uniquely positioning us to develop, test, and gain FDA approval for new cancer therapies. Responsibilities + Manage a complex and large ... + 1-2 years of experience in research administration. + Familiarity with FDA approval processes for cancer therapies. Work Environment You will be working… more
- North Coast Seafoods (Boston, MA)
- …of Good Manufacturing Practices and food safety regulations + Understand OSHA/ FDA /USDA requirements in a seafood manufacturing environment + Intermediate computer ... the following motions: bending, twisting, squatting and reaching + Exposure to FDA approved cleaning chemicals + Exposure to temperatures: <32 degrees Fahrenheit… more
- North Coast Seafoods (New Bedford, MA)
- …of Good Manufacturing Practices and food safety regulations + Understand OSHA/ FDA /USDA requirements in a seafood manufacturing environment + Intermediate computer ... the following motions: bending, twisting, squatting and reaching + Exposure to FDA approved cleaning chemicals + Exposure to temperatures: <32 degrees Fahrenheit… more
- Integra LifeSciences (Braintree, MA)
- …for backroom activities during external audits (eg, Notified Body audits, FDA inspections), including document management, SME coordination, and response strategies. ... Experience supporting external audits, including backroom coordination; experience with FDA inspections strongly preferred. + Strong written and verbal communication… more
- Oracle (Boston, MA)
- …Technical Staff to play a critical technical leadership role to ensure FDA and global regulatory compliance, including secure design, architecture and software ... following the Risk-Based Process and ensure product is maintaining compliance to FDA and other Global regulatory requirements. - Proficiency in the Java programming… more