- Takeda Pharmaceuticals (Lexington, MA)
- …deliver device clinical outcomes that exceed quality benchmarks and regulatory standards. **Core Responsibilities:** **Device Clinical Strategy & Risk Management:** ... into technical requirements + Coordinate risk mitigation activities across clinical, regulatory , quality, and engineering functions + Perform safety reviews on… more
- Sanofi Group (Cambridge, MA)
- …leading and overseeing all statistical work for clinical development and regulatory submissions, leading a team focused on clinical development strategies, ... Head partners closely with clinical teams, Clinical Sciences & Operations (CSO), regulatory experts, and key stakeholders to accelerate the delivery of medicines to… more
- Sanofi Group (Cambridge, MA)
- …strategic business support to maintain Sanofi's commitment to ethical practices and regulatory compliance. We are an innovative global healthcare company with ... monitoring program across multiple Business Units to ensure compliance with regulatory requirements, internal policies, and product messaging + Maintain robust… more
- Fujifilm (Boston, MA)
- …II + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and ... as mentoring Clinical Consultant, MI I and II. **Company Overview** At FUJIFILM Healthcare Americas Corporation, we're on a mission to innovate for a healthier… more
- Sanofi Group (Cambridge, MA)
- …program strategy and the network of collaborators from research to operational, regulatory , and commercial functions. Success in this role requires the ability to ... The GPH will be delegated such responsibilities as interaction with regulatory /health authorities, approval of protocols, informed consent documents, clinical study… more
- Merck (Boston, MA)
- …including response to product inquiries and adverse reports in accordance with internal, FDA , CFIA and USDA regulatory policies. The successful candidate for ... comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement… more
- Integra LifeSciences (Braintree, MA)
- …and analyze process data. + Assist in preparing for, and participating in FDA audits, internal audits, and other regulatory agencies audits. + Demonstrate ... you to do important work that creates change and shapes the future of healthcare . Thinking differently is what we do best. To us, change equals opportunity. Every… more
- Integra LifeSciences (Braintree, MA)
- …you to do important work that creates change and shapes the future of healthcare . Thinking differently is what we do best. To us, change equals opportunity. Every ... US Food and Drug Administration regulations, ISO 13485, and other applicable regulatory agencies as they pertain to laboratory testing. **ESSENTIAL DUTIES AND… more
- Integra LifeSciences (Braintree, MA)
- …and manage time to meet organizational goals and objectives. + Experience with External Regulatory Agency audits (ie, Notified Bodies and FDA ). + Knowledge of ... you to do important work that creates change and shapes the future of healthcare . Thinking differently is what we do best. To us, change equals opportunity. Every… more
- Integra LifeSciences (Boston, MA)
- …chance to do important work that creates change and shapes the future of healthcare . Thinking differently is what we do best. To us, change equals opportunity. Every ... and Drug Administration regulations, ISO 13485, and other applicable regulatory agencies as they pertain to laboratory testing. +...(CAPAs). + Assist in preparing for and participating in FDA audits, customer audits, etc. + All other duties… more