- Hologic (Marlborough, MA)
- …At Hologic we're searching for a **Principal Quality Assurance Engineer** to lead strategic initiatives that optimize and enhance our Quality Management System. In ... this role, you'll be responsible for ensuring compliance with global regulations, championing advanced quality tools, and driving continuous improvement across our… more
- Takeda Pharmaceuticals (Boston, MA)
- …my knowledge. **Job Description** **Objective:** **Principal responsibilities include:** + Serves as Global Safety Lead (GSL) and the Company-wide patient safety ... and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees. + Ensure communication of all safety information… more
- Lilly (Boston, MA)
- … documents (eg. IB, IND, IMPD, NDA/BLA, etc.) to support global regulatory submissions (including sections 2.6.4./non-clinical pharmacokinetics and ... clinic, as well as to design and support nonclinical and clinical studies, supporting global registration packages. * Lead R&D initiatives to grow and develop… more
- Ameresco (Westborough, MA)
- …customers reduce costs, enhance resilience, and decarbonize to net zero in the global energy transition. We are a trusted, full-service partner to public sector and ... Reliability Corporation (NERC) and Regional Entity standards. This role combines regulatory expertise with operational oversite to promote safe, reliable, and… more
- Medtronic (Boston, MA)
- …(https://www3.benefitsolver.com/benefits/BenefitSolverView?page\_name=signon&co\_num=30601&co\_affid=medtronic) **About Medtronic** We lead global healthcare ... schedule, cost, and quality, while adhering to safety and regulatory standards. * Manage project financials, including forecasting and...for Employers and the California Fair Chance Act. We lead global healthcare technology and boldly attack… more
- Rhythm Pharmaceuticals (Boston, MA)
- …Science to lead data-driven initiatives in support of our clinical, regulatory , and scientific objectives. The successful candidate will have a strong background ... Company Overview Rhythm is a global , commercial-stage biopharmaceutical company committed to transforming the...a growing biotech and directly impact research, development, and regulatory decision-making. Responsibilities and Duties + Lead … more
- Generac Power Systems (North Billerica, MA)
- …ensuring our energy storage systems and related technologies meet global safety, certification standards. This role blends hands-on design-for-compliance expertise ... the company in key standards committees to anticipate and influence regulatory changes. You will drive compliance strategy from concept through certification,… more
- Bristol Myers Squibb (Cambridge, MA)
- …Description** The Early Clinical Development - HOCT function is part of a global organization dedicated to the effective design and execution of early drug ... to support development, and + Serving as principal functional author for Regulatory submission, study reports, and publications + Provides oversight and medical… more
- Olympus Corporation of the Americas (Westborough, MA)
- …and governance supports business objectives through: proactive monitoring and application of global regulatory requirements within the regional QMS; leading the ... Systems sub-systems to improve Olympus compliance profile. + Monitors plans and applies Global regulatory or Olympus requirements into the QMS regionally and at… more
- Sanofi Group (Framingham, MA)
- …and supplier change notifications + Skilled in analyzing complex documentation for regulatory compliance + Strong knowledge of global pharmaceutical regulations ... Party Management Specialist **Location:** Framingham, MA **About the Job** Join a global network that powers how Sanofi delivers - seamlessly, purposefully, and at… more