Medical Device Complaint & Compliance Specialist

Cordis, LLC; Florida; On-site; USD 80,000 - 110,000; Full time

Job summary

Cordis, LLC is seeking a QA professional to review and manage medical device complaints, ensuring compliance with FDA and EU directives. The role involves investigating events, documenting findings, and supporting audits across regulatory frameworks.

Collaboration with sales and cross-functional teams is required to drive timely resolutions and maintain patient safety. The candidate will handle complex investigations, contribute to process improvements, and ensure rigorous documentation and

Qualifications

• Requires 3+ years of relevant experience with a Bachelor's degree; or equivalent education and experience.
• Advanced degree with no previous professional experience may be considered in some cases.

Responsibilities

• Review, evaluate, classify and follow up on product complaints related to identity, quality, safety and effectiveness of medical devices.
• Assess reporting criteria to government agencies to determine if events suggest a device caused or contributed to death or serious injury.
• Investigate and document field clinical events and follow up with Sales Representatives.
• Ensure compliance with FDA, EU Medical Device Directives (MDD) and other regulations governing adverse event reports (MDR/MDV).
• Assist audits and participate in internal and external audits as directed by management.
• Document technical operating procedures for system training and user certification.

Skills

Quality Assurance

Regulatory Compliance

Investigations

Audits

Medical Devices

Documentation

Education

Bachelor's degree

Job description

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)