Regulatory Affairs Associate Ii

Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed’s “Patients First!” culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.

I Am Abiomed | I Am Heart Recovery | Patients First!

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:

• Enjoy teamwork and thrive as a member of dynamic cross-functional teams
• Enjoy successfully prioritizing various tasks
• Embrace change, continuous learning, and work skills improvement
• 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
• Be energized by joining a world-class company and regulatory team!
• Build and maintain strong interpersonal relationships within and outside of the company
• 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

As a Regulatory Affairs Associate with ABIOMED, you will:

• Communicate regulatory plans and project status to internal stakeholders
• Participate in internal and external audits
• Actively participate on project teams
• Coordinate efforts associated with the preparation of regulatory documents and submissions for FDA
• Communicate with regulatory agencies (FDA) regarding clarification and follow-up of submissions under review
• Compile and maintain regulatory documentation databases and tracking systems
• 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, Annual Reports, IDEs, IDE Supplements, and Qsubs.

Required Education / Experience / Qualifications:

• Bachelor's Degree in Engineering or Science required (advanced degree preferred)
• Minimum of 2 years of experience working closely with Regulatory Affairs function; experience in a Regulatory Affairs role preferred
• Highly skilled in working on multiple parallel projects and adapting to changes when needed
• Excellent communication (verbal and written) and organizational skills
• Minimum of 2 years of technical, scientific and/or clinical experience in the medical device industry (Class III medical device experience strongly preferred)
• Self-starter with the ability to work independently and as an integral member of a high-performing team
• High attention to detail and ability to see and plan for the big picture

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.