Medical Device, Quality/Risk Management, Regulatory Compliance, US Regulatory Affairs
4 Year Degree
Are you a strong Regulatory Affairs professional who is fulfilled by contributing to an incredible mission, and seeing the tangible results of your work? Do you enjoy working with outstanding team members to generate wins for patients in need? If so, consider the following opportunity with ABIOMED's growing Regulatory Affairs team! The Regulatory Affairs Associate will be responsible for preparing regulatory documents and submissions according to Abiomed standards. Reporting directly to the head of our Global Regulatory Affairs organization, you will work closely with Regulatory Affairs team members and cross-functional staff members to support Regulatory programs. Through your engagement in this role, you will help shape the life-saving field of heart recovery!
The ideal candidate for this opportunity will:
Be passionate about Regulatory Affairs impact on the research, development, clinical, marketing, and production aspects of state-of-the-art class III cardiovascular medical devices
Be energized by joining a world-class company and regulatory team!
Enjoy teamwork and thrive as a member of dynamic cross-functional teams
Build and maintain strong interpersonal relationships within and outside of the company
Exhibit natural leadership traits: positive attitude, forward-looking, accountable, action-oriented, a focus on delivering results
Be adaptable and thrive in a dynamic work environment where variety is the routine
Embrace change, continuous learning, and work skills improvement
Enjoy successfully prioritizing various tasks
As a Regulatory Affairs Associate with ABIOMED, you will:
Focus on supporting activities that will enable Heart Recovery for more patients in need!
Prepare and review FDA submissions and other regulatory documents including 510(k)s, PMAs, PMA Supplements, and PMA Amendments
Actively participate on project teams
Communicate regulatory plans and project status to internal stakeholders
Communicate with regulatory agencies (FDA) regarding clarification and follow-up of submissions under review
Coordinate efforts associated with the preparation of regulatory documents and submissions for FDA
Compile and maintain regulatory documentation databases and tracking systems
Participate in internal and external audits
Required Education / Experience / Qualifications:
Bachelor's Degree in Engineering or Science required (advanced degree preferred)
Minimum of 2 years of technical, scientific and/or clinical experience in the medical device industry (Class III medical device experience strongly preferred)
Minimum of 2 years of experience working with Regulatory Affairs function; experience in a Regulatory Affairs role preferred
Excellent communication and organizational skills
Internal Number: 1934
Abiomed, an innovative medical device company, is focused on recovering hearts and saving lives. We have a single guiding mission: “Patients First.” With corporate headquarters in Danvers, Massachusetts, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed’s 1,000 employees form one of the fastest growing medical technology companies in the world. Abiomed attracts and retains exceptional talent with our collaborative culture, passion for our work, and a strong commitment to employee professional development.