Overview

When you join the team at Cordis, you become part of an inspiring mission to save lives, impacting millions of people and broadening access to life-saving cardiovascular and endovascular technology. As a global leader for over 60 years, we are dedicated to being the heart of innovation to transform cardiovascular care.

At Cordis, we're teammates, not just employees. We embrace an empowered and one-team culture where teammates are inspired to unleash their full potential. With diverse teams on a global scale, we believe the richness of our experiences and backgrounds enhances the careers of our teammates, the service to our customers, and ultimately, the lives of our patients.

If you love a challenge and are ready to have a direct, transformative and positive impact on the lives of millions, then Cordis is just the place for you.

We are the people behind the people who keep saving lives.

Responsibilities

Review, evaluate, classify and perform follow-up activities on all Product Complaints relative to the identity, quality reliability, safety and effectiveness of medical devices. Evaluates for reporting criteria to Government Agencies to determine if the event reasonably suggests a device may have or could have caused or contributed to a death or serious injury.

Works independently on and resolves complex issues

Has conceptual understanding of QA functions

Prioritizes work to meet deadlines

Suggests and implements tactical direction for functional area

Investigates and processes product complaints while maintaining compliance to all regulations

Investigation and documentation of field clinical events and follow-up with Sales Representatives

Accountable for compliance with all Food & Drug Administration (FDA), European Union Medical Device Directives (MDD) and other regulations governing adverse event reports such as Medical Device Reports (MDR), Medical Device Vigilance (MDV) and other reports.

Evaluates Product complaints for MDR/MDV/Other regulatory agencies as applicable

Under the direction of Department management, is an active participant during internal and external audits

Devises new approaches to problems encountered

Document technical operating procedures for system training and user certification

Together with Supervisor/Manager plan and implement short-term and long-term projects

Performs planned, periodic audits of Coordinators' and Analysts' work to ensure compliance to departmental procedures and all applicable government regulations

Documents audit results in written audit reports that are distributed and reviewed by department management

Work requires a broad knowledge of Cordis products and clinical applications of such products

Assist with review of analysis reports and preparation of customer responses

Independently performs assignments with instructions as to the general results expected

Performs work, which involves conventional complaint handling processes but may include a variety of complex investigations and follow-ups

Responsible for communicating business-related issues or opportunities to next management level

Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance

Practices company safety, quality policies and procedures, actively requires conformance

Qualifications

Required Qualifications

Requires a minimum 3+ years of relevant experience with a Bachelor's degree; or equivalent education and experience; Or an advanced degree with no previous professional experience.Where required, the role must hold an appropriate degree in the industry (eg. Legal)

Preferred Qualifications

Interventional Radiology/Cardiology or ICU experience preferred

3+ years of related experience and/or training preferred

Experience using vascular interventional devices is preferred

Equivalent combination of education and experience

Experience in the medical device industry preferred

Knowledge of Medical Device Complaint Handling and Reporting Regulations

Department Management could evaluate and substitute any of the educational requirements by demonstrated experience in the field.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES and CERTIFICATIONS/LICENSES:

Healthcare Certification and/or license in specific discipline preferred

Knowledge of product use in a clinical setting preferred

Excellent written and oral English communication skills

Proficient investigative and analytical skills

Computer literate of MS Word, MS PowerPoint, MS Excel preferred

Ability to interact with individual/groups at all levels, good presentation/training skills

Ability to identify priorities and function independently

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one's identity. All our teammate's points of view are key to our success, and we believe inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable and welcoming.

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Joining our Talent Community is a great way to receive company news and updates, as well notifications on career opportunities and events that interest you! Please tell us more about yourself so we can align you with future opportunities that match your background, skills and interests.

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Job Locations US-FL-Miami Lakes

ID 2026-13296

Category Quality/Regulatory

Position Type Regular Full-Time

CORDIS is proud to be an equal opportunity employer, values diversity in all its forms is and committed to fostering an inclusive work environment. We are committed to advancing our culture of belonging, where all teammates feel seen, heard, and appreciated and encouraged to be their authentic selves. Our team is invested in attracting, retaining and growing top talent. Our Teammates are the core of our innovation and success. Cordis is an inclusive, engaging place to work and grow a career. CORDIS is committed to offering reasonable accommodations, upon request, to job applicants with disabilities. If you need assistance or an accommodation due to a disability, please contact GlobalHR@Cordis.com

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