Regulatory Affairs Co-op

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

Qualifications

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
• T eam 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.