- J&J Family of Companies (Danvers, MA)
- …**Responsibilities:** + Collaborate with cross functional teams including post market quality engineering, product security and medical office in assessment & ... applications on real-time operating systems. + Good understanding of FDA 524B cybersecurity guidelines. + Comfortable with system-level troubleshooting using… more
- ConvaTec (Lexington, MA)
- …relevant experience in research and development + Experience developing medical devices under quality systems compliant with ISO 13485 and FDA requirements + ... Strong interpersonal and leadership skills, with a track record of effective collaboration across both internal and external stakeholders. + Expertise in tissue culture, cell culture, biochemistry and molecular biology particularly where medical devices… more
- Sanofi Group (Cambridge, MA)
- …a highly visible and priority launch asset for Sanofi Specialty Care. Since its FDA approval in 2023, ALTUVIIIO has been steadily gaining market share and represents ... family, with a wide range of health and wellbeing benefits including high- quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral… more
- Charles River Laboratories (Shrewsbury, MA)
- …the world. At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of ... proudly supported the development of 86% of the drugs approved by the FDA in 2021. **Equal Employment Opportunity** Charles River Laboratories is an Equal… more
- Wolters Kluwer (Waltham, MA)
- …well understood, technically feasible, and delivered on time and with quality . * Collaborate with go-to-market teams (Marketing, Sales, Pricing, Customer Experience) ... regulatory published drug information and policy data sources (CMS, FDA , etc.) covering drug control/compliance programs, covered programs (Medicare/Medicaid) and… more
- Beth Israel Lahey Health (Burlington, MA)
- …of all aspects of clinical trials research complying with research SOPs, GCP, FDA and OHRP regulations; ensures adherence to regulations and educates study team ... to Customer Service standards.** **Participate in departmental and/or interdepartmental quality improvement activities.** **Participate in and successfully completes Mandatory… more
- Fujifilm (Boston, MA)
- …the business, to work on customer systems. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that all job ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- Takeda Pharmaceuticals (Boston, MA)
- …technical and administrative staff at CROs or external vendors to deliver high quality results in a fast-paced environment. + Manages or leads projects across the ... global regulatory guidelines, expectations and corresponding industry best practices (eg, FDA guidelines, Good Laboratory Practices (GLP)) + Experience in managing… more
- Rhythm Pharmaceuticals (Boston, MA)
- …and implementation of corrective and preventive actions, as needed. + Performs quality review of SAEs and SUSARs from clinical trials and post-marketing and ... 1-2 years of Drug Safety and Pharmacovigilance experience. + Knowledge of FDA , ICH, EU Regulations and Requirements for Pharmacovigilance required. + Solid… more
- Sanofi Group (Cambridge, MA)
- …the clinical part of submission dossier for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China and answers to questions ... family, with a wide range of health and wellbeing benefits including high- quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral… more