Regulatory Affairs Co-Op Jobs

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!

Fall Co-op Program: July 11 - December 15, 2023

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:

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

REQUIREMENTS:

• Junior, Senior, or Grad student pursuing a degree in mechanical, biomedical engineering, or directly related discipline

• Motivated self-starter who is keen to build regulatory knowledge
• Knowledge of medical device regulations (e.g. US and EU)
• Team player
• Demonstrated communication skills, both written and verbal

• Applicants must be authorized to work for any employer in the US. We we will not be able to provide employment to anyone that requires sponsorship now or in the future.

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.