Abiomed is a pioneer and global leader in healthcare technology and innovation, with a mission ofRecovering Hearts & Saving Lives. With corporate headquarters in Danvers, Massachusetts, and offices in Baltimore, MD, Woburn, MA, Aachen & Berlin, Germany and Tokyo, Japan, Abiomed's 2,000 employees form one of the fastest growing medical device companies in the world. We attract and retain exceptional talent with our collaborative culture, passion for our work, and a strong commitment to employee professional development.
Patients First | Innovation | Winning Culture | Heart Recovery
The Manager, Global Clinical Compliance is responsible for ensuring that clinical studies are executed in accordance with applicable international, federal, and local regulations, Good Clinical Practices (GCP), and Abiomed internal Standard Operating Procedures (SOPs). She/he will serve as a resource for clinical study teams to instill regulation awareness and promote a constant state of inspection readiness, inclusive of identifying potential risks and advising on solutions to ensure high quality clinical evidence is generated in support of clinical study tactical plan objectives. She/he will conduct routine quality checks of clinical studies to ensure that quality records are accurate, complete, and contemporaneous. She/he will take an ownership role of the Clinical Quality System, ensuring alignment with regulations, GCP, and corporate quality standards; leveraging internal subject matter experts (SMEs) to develop content aligned with current practice, and developing effective training programs to ensure that associates have the knowledge and skill to perform their essential duties. The Manager, Global Clinical Compliance will work closely with Quality Assurance to manage health authority inspections, schedule and align on internal audit objectives, and manage Corrective and Preventative Actions (CAPA).
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Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.Abiomed maintains a drug-free workplace.