Senior Regulatory Affairs Specialist Jobs in Cambridge, MA

Pioneer a comprehensive Computer System Validation strategy across GxP systems. Collaborate with Quality and IT to drive compliance and data integrity while enhancing efficiency in validation processe...

Shape the future of healthcare by driving sales growth in a defined territory. Collaborate with healthcare providers, leverage insights, and strategically manage accounts while launching a first-in-cl...

Lead the charge in strategic sales growth and relationship-building within the healthcare market. Drive product adoption by delivering tailored solutions and engaging key stakeholders to address signi...

Drive system engineering excellence by evaluating programs, performing validations, and enhancing technical processes to ensure subsystems meet design specifications while providing engineering suppor...

Oversee supplier quality activities for NPI and production, ensuring compliance with ISO 13485 and regulatory standards. Drive supplier qualification and performance management, collaborating cross-fu...

Drive operational excellence by managing regulatory affairs processes and supporting scalable promotional material reviews. Collaborate cross-functionally to enhance compliance, training, and automati...

Optimize systems engineering support across the acquisition lifecycle for dynamic Department of the Air Force initiatives, translating operational requirements into technical solutions that enhance mi...

Lead nonclinical safety strategies in Oncology, guiding pivotal clinical trials and regulatory submissions. Collaborate globally to ensure scientific excellence and build trust across diverse teams, i...

Lead the charge in driving service contract sales and renewals, managing a diverse pipeline, and collaborating cross-functionally to achieve revenue growth within a defined territory while enhancing c...

Shape the future of energy by collaborating on the design and upgrade of complex electrical systems for power plants. Engage in a dynamic project team, producing detailed wiring diagrams and supportin...

Lead innovations in complex system development, driving solutions for the Electrophysiology product portfolio. Collaborate with cross-functional teams to ensure successful product lifecycle management...

Lead the design and execution of in-vitro ADME assays, enhancing lab automation capabilities to provide high-quality data for drug discovery and development decision-making while managing project time...

Manage the development and execution of test strategies for complex systems. Collaborate with cross-functional teams to ensure compliance and performance metrics are met, supporting global communicati...

Empower your career by leading complex test strategies for advanced communication systems. If you thrive in a collaborative environment and excel in system evaluations, join us to influence global mil...

Unlock your potential as a key leader in GxP auditing, driving compliance and quality oversight across computerized systems in regulated environments. Collaborate cross-functionally to enhance risk ma...

Unlock potential by driving technical sales in the gene therapy sphere, managing demos, and accelerating product adoption. Collaborate with Central Sales to convert opportunities and support long-term...

Accelerate progress at drug product manufacturing by leading quality assurance efforts, ensuring compliance, and driving continuous improvement across GxP activities for successful late-stage developm...

Champion innovative treatments by coordinating clinical trial documentation, ensuring meticulous management of the Trial Master File, and supporting the research team in various operational aspects fo...

Empower success by leading validation activities for regulated computerized systems. Collaborate cross-functionally to ensure compliance with regulatory standards, quality assurance, and risk-based me...

Lead quality engineering initiatives to ensure compliance and product excellence. Collaborate across teams to develop quality strategies, conduct risk assessments, and implement continuous improvement...

Manage comprehensive risk-based quality audits across multiple sites, ensuring compliance with GCP standards. Collaborate globally with cross-functional teams to enhance clinical study integrity and c...

Transform the Quality Training program by developing and delivering engaging training that empowers employees with essential skills and knowledge across the organization, ensuring compliance with regu...

Shape quality improvements by leading CAPA processes and ensuring compliance with regulations in a cross-functional team. Engage in internal and external audits while enhancing training for the Qualit...

Shape quality improvements by managing corrective actions in a cross-functional setting. Enhance internal audits and engage in external audits while maintaining regulatory compliance and supporting qu...

Champion quality assurance initiatives by leading food safety and compliance efforts. Drive excellence across operations, develop effective quality cultures, and mentor teams to ensure adherence to st...