- Sanofi Group (Cambridge, MA)
- …endpoint strategy implementation + Knowledge of the drug development process and the regulatory ( FDA , EMA, local agencies) and payer (EUnetHTA, NICE, HAS, G-BA, ... new COA instruments; the development of briefing books or dossiers for regulatory consideration of COAs Internal customers include primarily Research and Development… more
- Abbott (Westford, MA)
- …high performing team. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... Abbott is a global healthcare leader that helps people live more fully...manufacturing and that product meets all design, manufacturing, and regulatory requirements. + Ensure a safe work environment consistent… more
- Medtronic (Boston, MA)
- … healthcare industry. + Strong understanding of cybersecurity frameworks, regulatory requirements, risk management, and industry best practices (eg, HIPAA, NIST, ... can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down… more
- Medtronic (Boston, MA)
- …can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down ... Ensure all software verification activities adhere to relevant medical device regulations (eg, FDA 21 CFR Part 820, ISO 13485, IEC 62304) and internal quality… more
- Fujifilm (Boston, MA)
- …Manager. + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... by the Area Service Manager. **Company Overview** At FUJIFILM Healthcare Americas Corporation, we're on a mission to innovate...a must along with ability to maintain paperwork to FDA and company required standards. + Excellent analytical and… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... customer sites as directed by service management. **Company Overview** At FUJIFILM Healthcare Americas Corporation, we're on a mission to innovate for a healthier… more
- United Therapeutics (Boston, MA)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... in trust and collaboration. You naturally spot the needs of patients and healthcare providers, and you love coming up with thoughtful, strategic ideas that turn… more
- Sanofi Group (Cambridge, MA)
- …cutting-edge science into US clinical practice. We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, ... medical science, clinical trials, marketing strategies, and key publications. + ** Regulatory and Compliance Oversight** : Oversee the medical review and approval… more
- Wolters Kluwer (Waltham, MA)
- …planning, and defining and tracking success metrics. * Leverage knowledge of US healthcare government and regulatory published drug information and policy data ... machine-readable formats and SaaS-based solutions that power decision-making across the healthcare ecosystem. The Lead Product Manager translates customer and market… more
- Nanobiosym, Inc. (Cambridge, MA)
- …Massachusetts, Nanobiosym was awarded the first X-Prize to be given for healthcare . The Compliance Engineer is responsible for the organization and the coordination ... of processes pertaining to regulatory compliance and quality systems to ensure ...creation and documentation of validation protocols that comply with FDA regulations. + Provide troubleshooting focus and direction for… more
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