About this opportunity
Cordis lists this Specialist II Post Market Vigilance (United States) opportunity in town of florida, New York. Review the employer’s description below for duties, qualifications and application requirements.
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)
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
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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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.