Post-Market Surveillance Intern - Medical Device

Job Description

Company Overview

At Bracco Medical Technologies, every employee has an impact on our Mission to empower lifesaving decisions. We create medical devices that give healthcare providers the insights they need to confidently and safely diagnose patients. Our unique line of products includes Intravascular Ultrasound (IVUS), Fractional Flow Reserve (FFR), Cardiovascular Imaging contrast delivery (CVi), and CT and MRI contrast delivery systems. As part of the Bracco Group, Bracco Medical Technologies benefits from the resources of a multinational conglomerate with broad expertise in cath lab and radiology suite technology and a dedication to continuous advancement.

We are currently seeking intern / co-op candidates to learn with us as they engage in a variety of hands-on projects alongside our high-performing and authentic Quality team.

Position Summary

The Post-Market Surveillance Intern will report directly to the Post-Market Surveillance Specialists and assist with various projects in ensuring continued compliance of Bracco Medical Technologies to medical device standards and regulations. This includes assisting with complaint triage, complaint processing, and preparation of complaint trending data. Additionally, there will be opportunities to assist with the preparation of adverse event reports to regulatory agencies (e.g., US FDA MedWatch reporting, European Manufacturer's Incident reporting, and others). This internship provides an opportunity to learn about the global complaint and adverse event reporting regulations and requirements that governments around the world require to be in place for post-market surveillance of medical devices to ensure safe and reliable medical devices are available for global customers.

This role will provide the opportunity to develop the knowledge and gain the experience necessary to launch a future career in Post-Market Surveillance in the Medical Device industry.

Responsibilities

• Assist with triage and processing of complaints, under the direction of the Post-Market Surveillance Specialists.
• Prepare customer response letters, which provide the results of the investigation to the end customer.
• Assist with preparation of complaint data for complaint review meetings, trend analysis, Key Quality Metrics (KQM), corrective and preventive action (CAPA) verification of effectiveness, and per other department requests.
• Assist with the preparation of adverse event reporting and product problem reporting per global regulation.
• Provide support in reviewing and updating Post-Market Surveillance standard operating procedures, work instructions, and forms. This will include preparation of document redlines and generation of the Change Order in the document control system.
• Assist with / contribute to continuous improvement projects.

Training to be provided

Students will be exposed to working with various quality processes within the Bracco Medical Technologies (BMT) organization. They will learn key requirements which need to be followed in a regulated environment such as the medical device industry. Product-specific training will be provided to ensure the intern has adequate technical knowledge of the medical device to facilitate complaint triage and complaint processing.

Additionally, our interns and co-ops benefit from a buddy program, career development programming, and opportunities to build their professional networks virtually and in-person with BMT professionals.

Qualifications

Minimum :

Preferred :

Job Location

Term / Hours

To learn more about Bracco Medical Technologies, please visit our website at : https : / / careers.braccomedtech.com.

Bracco Medical Technologies is an equal opportunity / affirmative action employer.