Cordis · 5 hours ago
Specialist II Post Market Vigilance (United States)
Miami Lakes, FL
Full-time
Onsite
Mid Level
3+ years expCordis is a global leader in cardiovascular and endovascular technology, dedicated to saving lives and transforming cardiovascular care. The Specialist II Post Market Vigilance will review and evaluate product complaints, ensuring compliance with regulations and participating in audits while maintaining high standards of quality and safety.
Health CareHealth DiagnosticsMedical
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
Qualification
Required
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
Interventional Radiology/Cardiology or ICU experience 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
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
Company
Cordis
Cordis Corporation, a Johnson & Johnson company, has pioneered less invasive treatments for vascular disease.
1001-5000 employees
H1B Sponsorship
Cordis has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (3)
2023 (3)
2022 (4)
Funding
Current Stage
Late StageTotal Funding
unknown2021-03-12Acquired
Leadership Team
Scott Drake
Chief Executive Officer
Recent News
2025-11-11
TeamBest Global Companies
2025-11-07
News-Medical.Net
2025-11-01
Company data provided by crunchbase