- Mentor Technical Group (Boston, MA)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With… more
- Sumitomo Pharma (Cambridge, MA)
- …Summary of Efficacy (ISE) strategy for NDA/BLA submissions, ensuring compliance with regulatory expectations. + Collaborate closely with cross-functional ... Perform programming validation for key derived datasets and oversee Quality Control (QC) efforts to ensure accuracy in data...Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations is a plus… more
- Integra LifeSciences (Braintree, MA)
- …+ Ensure compliance with safety, environmental, and regulatory standards (eg, FDA , ISO). + Maintain accurate records of refrigerant usage and system performance. ... regulated industries and a strong understanding of refrigeration systems, compliance standards, and preventive maintenance practices. **Key Responsibilities:** +… more
- Integra LifeSciences (Mansfield, MA)
- …cover sterilization programs across sites. + Obtains and maintains knowledge of FDA , ISO, and EN sterilization and related microbiology standards and guidelines, for ... 11137, ISO 11135 and environmental monitoring requirements. + Supports EU MDR compliance by performing gap analysis and formulating gap resolution plans + Subject… more
- Lawrence General Hospital (Methuen, MA)
- …laboratory environment meets both regulatory standards and the institution's quality requirements. By coordinating with healthcare professionals, the coordinator ... responsibilities include training non-laboratory personnel, maintaining equipment, and ensuring compliance with all relevant policies and procedures. Through their… more
- Sanofi Group (Framingham, MA)
- …standards. + Implementing process improvements to enhance efficiency, safety, and quality within the engineering and maintenance groups. + Selection and management ... Performs strategic planning and development activities for site CQ, including compliance , capacity, timeline and direction. + Align department objectives with… more
- Takeda Pharmaceuticals (Lexington, MA)
- …responses, including clinical dossiers. + Responsible for ensuring team provides high- quality , balanced and timely medical information for multiple products upon the ... alignment with USM Medical Strategies, and support the delivery of high- quality product information, promotional product communications, and other medical and… more
- Stantec (Boston, MA)
- …us create buildings that matter to our world. Together, we are enhancing the quality of life globally through design. Join us and design your place with Stantec. ... related to bio-pharmaceutical dosage forms, nutraceutical facilities and other regulated FDA or similar facilities where drug products are manufactured, stored in… more
- Sanofi Group (Cambridge, MA)
- …Ready to get started? **Main responsibilities:** + Draft and prosecute high- quality patent applications for medical devices and drug delivery systems, leveraging ... AI tools to enhance efficiency and quality . + Collaborate with in-house attorneys and outside counsel to assess inventions, determine patentability, and develop… more
- Medtronic (Newton, MA)
- …debugging software that interfaces with hardware components. Experience with regulatory compliance and security protocols specific to medical software (eg, HIPAA, ... FDA regulations) is preferred but not required. The ideal...with cross-functional teams, including hardware engineers, product managers, and quality assurance, to define software requirements and deliver high-… more