Job Description

Abiomed is an innovative medical device business with an inspiring mission "Patients First," and a unique guiding company principle " Recovering hearts. Saving lives." With more than 2,000 employees, Abiomed is one of the fastest growing medical technology businesses in the world with corporate headquarters in Danvers, USA, and locations in Aachen and Berlin, Germany, Tokyo, Japan, and Singapore. Abiomed is part of Johnson & Johnson MedTech. Abiomed is an employer with attractive working conditions and an appreciative corporate culture that focuses on the needs of its employees. Abiomed inspires and retains exceptional talent through collaboration, passion and continuous development. Abiomed is a pioneer and global leader in healthcare technology and innovation, with a mission of Recovering Hearts & Saving Lives. With corporate headquarters in Danvers, Massachusetts, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed’s 1.400 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.Abiomed, maker of the Impella heart pump, has the immediate opportunity for a Clinical Regulatory Affairs professional to join its growing, dynamic team. In this important and exciting role, the Clinical Regulatory Affairs Specialist(m/f/d) will be responsible for regulatory aspects of Abiomed driven clinical trials. This responsibility comprises submissions to Competents Authorities and Ethics Committees for initial approvals, amendments, safety and periodic reporting. The trial portfolio includes early feasibility studies for product development, initial CE marking of new product lines, label expansion, and post-market clinical follow-up studies. Regional focus is in Europe, but other jurisdictions, e.g. in the Asia-Pacific region, may be added later. The Clinical Regulatory Affairs Specialist will also play an essential role in meeting post-market surveillance (PMS) requirements and completing PMS docmentation. Reporting directly to the head of EMEA & APAC Regulatory Affairs, this person will partner closely with the Clinical Affairs, Medical Office, Marketing, Product Development, and Complaints departments to implement the global Abiomed trial and post-market surveillance strategies.