Medical Device Quality & Regulatory Specialist II

Cordis; Florida; On-site; USD 65,000 - 90,000; Full time

Job summary

Cordis is seeking a Product Complaint Analyst in New York to review, evaluate, classify and follow up on product complaints for medical devices, ensuring compliance with FDA MDR/MDV and other regulations. The role requires independent work on complex issues and close collaboration with management.

You will support audits, document procedures, and participate in regulatory reporting while maintaining high standards of quality and patient safety.

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.

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
• 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 FDA, EU Medical Device Directives and other regulations governing adverse event reports
• Under the direction of Department management, participates in audits
• Documents audit results in written reports
• Broad knowledge of Cordis products and clinical applications
• Assist with review of analysis reports and preparation of customer responses
• Independently performs assignments with instructions
• Performs complex investigations and follow‑ups
• Communicates business issues or opportunities to management
• Ensures compliance with regulations, policies and procedures

Skills

Investigative skills

Regulatory knowledge

Medical device experience

Written & verbal comms

Education

Bachelor's degree in a related field

Tools

MS Word

MS Excel

MS PowerPoint

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.

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.