DESCRIPTION

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, 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

POSITION SUMMARY

Our Regulatory Affairs team supports Abiomed in navigating complex regulatory landscapes to bring the latest innovations in heart recovery to our patients. We are looking for a co-op who will be fully integrated as a member of our team, achieving global regulatory approvals, registrations, and licenses for our products and services while ensuring compliance with global regulations and internal procedures.

KEY RESPONSIBILITIES:

The co-op will:

• Assist in completing/documenting global regulatory assessments for changes to medical devices
• Attend project team meetings with Regulatory Affairs lead
• Prepare and maintain Regulatory Affairs data and metrics
• Evaluate current processes and propose opportunities for internal efficiencies
• Compile and/or write regulatory dossiers for global submissions

REQUIREMENTS:

• Junior, Senior, or Grad student pursuing a degree in mechanical, biomedical engineering, or directly related discipline
• Demonstrated communication skills, both written and verbal
• Knowledge of medical device regulations (e.g. US and EU)
• Motivated self-starter who is keen to build regulatory knowledge
• Team player

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.

Push the boundaries of science to transform health—and your career.

Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.

Accelerate your career while changing the world.

Each of our broadly-based family of companies offers an inclusive and empowering culture and employee benefits (like paid time off to volunteer, transgender-inclusive and same-sex partner health insurance coverage, and more) designed to help you live your best life, however you define it. And our best-in-class learning and development approaches, mentorship, and access to innovators across the world will help you grow your skills and reach your career goals. Because when you're at your best, nothing stands between you and your next breakthrough.