Johnson & Johnson companies are equal opportunity employers.
Director, Complaint Handling & Product Safety-5602140304
Description
Cordis Corporation, a member of Johnson & Johnson's Family of Companies, is recruiting for a Director, Complaint Handling & Product Safety to be located in Miami Lakes, FL.
Cordis is a recognized leader in providing physicians with breakthrough treatment solutions for peripheral vascular disease, a leader in circulatory disease management, interventional cardiology, radiology and electrophysiology products for circulatory disease management.
Over the last 50 years, a deep understanding of the medical marketplace, unrivaled concern for the needs of patients, and high impact technological innovation have made Cordis a strong developer of breakthrough products for interventional medicine, minimally invasive computer-based imaging and electrophysiology. Today, Cordis employees from around the world share a strong commitment to continue our company's groundbreaking work.
The Director, Complaint Handling & Product Safety assures that processes and systems are in place to detect and monitor product safety and performance signals through management of the product complaint and risk management system. The role evaluates product risk and potential safety issues; completes health hazard analyses with supporting documentation. The individual assesses serious injuries, malfunctions and drug interactions in support of regulatory agency product surveillance reporting. He/she ensures that product safety and performance analyses are data driven and scientifically sound. The Director manages the worldwide complaint organization, including product safety reports for marketed products. The role communicates product safety and performance issues to management and appropriate individuals. The individual recommends appropriate actions and ensures personal and company compliance with all local government and company regulations, policies and procedures for health, safety and environment. He/she ensures conformance to company safety and quality procedures. The Director uses familiarity with industry principles of adverse event reporting requirements to ensure compliance. The individual has a working knowledge of product risk management including FMEA methodology for both pre-market development activities and post market safety surveillance activities. The role ensures Medical oversight of risk management activities in both the pre-market and post-market phases of product life cycle.
The Director, Complaint Handling & Product Safety is responsible for communication business related issues or opportunities to next management level. The individual is responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition. He/she is responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies and procedures. The Direct will also perform other duties assigned as needed.
Qualifications
A minimum of a Bachelors Degree or equivalent is required. A minimum of 10 years of related experience is required. Previous management experience is required, including line management of multiple levels of reporting. Relevant clinical experience in a hospital setting is preferred. Previous experience within the medical device industry is required. Working knowledge of ISO 14971:2012 and ISO 13485 is required. Working knowledge of FDA complaint handling and MDR regulations is required. Working knowledge of MEDDEV guidelines on vigilance reporting is required.
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI NA
Primary Location:North America-United States-Florida-Miami Lakes
Organization: Cordis Corporation (6017)
Job Function: Quality Assurance
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement
Director, Complaint Handling & Product Safety-5602140304
Description
Cordis Corporation, a member of Johnson & Johnson's Family of Companies, is recruiting for a Director, Complaint Handling & Product Safety to be located in Miami Lakes, FL.
Cordis is a recognized leader in providing physicians with breakthrough treatment solutions for peripheral vascular disease, a leader in circulatory disease management, interventional cardiology, radiology and electrophysiology products for circulatory disease management.
Over the last 50 years, a deep understanding of the medical marketplace, unrivaled concern for the needs of patients, and high impact technological innovation have made Cordis a strong developer of breakthrough products for interventional medicine, minimally invasive computer-based imaging and electrophysiology. Today, Cordis employees from around the world share a strong commitment to continue our company's groundbreaking work.
The Director, Complaint Handling & Product Safety assures that processes and systems are in place to detect and monitor product safety and performance signals through management of the product complaint and risk management system. The role evaluates product risk and potential safety issues; completes health hazard analyses with supporting documentation. The individual assesses serious injuries, malfunctions and drug interactions in support of regulatory agency product surveillance reporting. He/she ensures that product safety and performance analyses are data driven and scientifically sound. The Director manages the worldwide complaint organization, including product safety reports for marketed products. The role communicates product safety and performance issues to management and appropriate individuals. The individual recommends appropriate actions and ensures personal and company compliance with all local government and company regulations, policies and procedures for health, safety and environment. He/she ensures conformance to company safety and quality procedures. The Director uses familiarity with industry principles of adverse event reporting requirements to ensure compliance. The individual has a working knowledge of product risk management including FMEA methodology for both pre-market development activities and post market safety surveillance activities. The role ensures Medical oversight of risk management activities in both the pre-market and post-market phases of product life cycle.
The Director, Complaint Handling & Product Safety is responsible for communication business related issues or opportunities to next management level. The individual is responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition. He/she is responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies and procedures. The Direct will also perform other duties assigned as needed.
Qualifications
A minimum of a Bachelors Degree or equivalent is required. A minimum of 10 years of related experience is required. Previous management experience is required, including line management of multiple levels of reporting. Relevant clinical experience in a hospital setting is preferred. Previous experience within the medical device industry is required. Working knowledge of ISO 14971:2012 and ISO 13485 is required. Working knowledge of FDA complaint handling and MDR regulations is required. Working knowledge of MEDDEV guidelines on vigilance reporting is required.
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI NA
Primary Location:North America-United States-Florida-Miami Lakes
Organization: Cordis Corporation (6017)
Job Function: Quality Assurance
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement