- Teleflex (Chelmsford, MA)
- …have capability within engineering disciplines to support Manufacturing and Quality Compliance efforts throughout the business. Provide support as an engineering ... the manufacturing line to reduce costs, while maintaining quality compliance , using the application of lean problem- solving tools....and Test Method Validation (TMV) in accordance with ISO, FDA and corporate guidelines. * Keep track of industrial… more
- Nanobiosym, Inc. (Cambridge, MA)
- …of secure firmware update protocols and architecture. + Experience with medical device compliance and documentation as per FDA and ISO13485 standards + PhD ... communicate clearly with team to document designs, review code, and ensure compliance with security and performance guidelines. Qualifications: + Essential: + Proven… more
- Stantec (Boston, MA)
- …related to bio-pharmaceutical dosage forms, nutraceutical facilities and other regulated FDA or similar facilities where drug products are manufactured, stored in ... and automated systems which require qualification and validation for compliance . The commissioning and validation of equipment, facilities, utility systems… more
- Stantec (Devens, MA)
- …environment with cross-functional teams. - Familiarity with GMP regulations, FDA standards, and validation protocols. - Experience supporting capital projects ... know if this should be included. **Pay Transparency:** In compliance with pay transparency laws, pay ranges are provided...or any other condition of employment. Stantec is in compliance with laws and regulations and ensures equitable opportunities… more
- Grifols Shared Services North America, Inc (Worcester, MA)
- …teams of needed updates/changes **Additional responsibilities:** + Represent R&D Compliance in professional and industry organizations. **Knowledge, skills, & ... abilities:** Knowledge and understanding of FDA regulations for the biotechnology and pharmaceutical industry. Understanding...to evaluate complex issues and meet deadlines to ensure compliance , as well as business timelines to accomplish company… more
- Sumitomo Pharma (Boston, MA)
- …oncology, and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and ... (written, verbal, electronic, etc.) that an employee encounters is considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable… more
- Capgemini (Burlington, MA)
- …will drive verification strategies, manage a team of engineers, and ensure compliance with medical device regulations. **Your Role** . Lead Verification Strategy: ... for embedded firmware, mobile applications (iOS/Android), and integrated systems. . Compliance & Standards: Ensure all verification activities align with relevant… more
- Chiesi (Boston, MA)
- …ecosystems. + Direct global early access and compassionate use programs, ensuring compliance with varied regulatory frameworks (eg, FDA , EMA, and other ... to integrate AI solutions (eg, predictive modeling, automated content generation, compliance monitoring) into core workflows. + Stay ahead of technological trends… more
- Charles River Laboratories (Cambridge, MA)
- …rack sanitation, PPE/supply stations and waste management). + Ensures compliance and documentation with all institutional and regulatory protocols, policies, ... wash team operations. + Continuously support vivarium management in maintaining compliance with all internal (IACUC) and external (USDA-APHIS, PHS-OLAW,) regulatory… more
- Beth Israel Lahey Health (Burlington, MA)
- …and support to staff as needed.** **Oversees and ensures staff compliance with the research protocols of the department.** **Utilizes problem-solving skills ... of all aspects of clinical trials research complying with research SOPs, GCP, FDA and OHRP regulations; ensures adherence to regulations and educates study team… more