Product Safety Clinician

Cordis
Miamigardens, FL
29 Apr 2024

Vacancy expired!

Summary: Works as a member of the Post Market Surveillance/Risk Management team responsible for activities related to product safety, post market surveillance and risk management. This position will be responsible for post market surveillance activities, health hazard evaluations, safety investigations, complaint analysis, risk management documentation, review of published literature, escalation procedures an execution of processes for safety assessments and surveillance for the global Medical Safety Program for medical devices. The Clinician will report to the Manager Product Safety/Risk Management. The Safety Specialist will work collaboratively with key team members including, Quality, Sales & Marketing, Medical Affairs, Regulatory Affairs, Post-Market Vigilance (PMV), Legal, Manufacturing, New Product Development, New Business Development, Base Business, Clinical Affairs, Risk Management departments as well as with senior leadership. The Safety Specialist will provide clinical expert knowledge to the business to identify hazards involved with the use, design and manufacture of medical devices, estimating and evaluating any associated risks and using the risk analysis process to take steps to control or eliminate these risks helping to facilitate medical safety evaluations and decisions.

Essential Roles and Responsibilities:
  • Reviews and codifies field complaints, interprets facts related by end user and extrapolates into complaint data
  • Interprets complaint data for PMS and Quality departments
  • Provide clinical guidance and validate correct coding and regulatory reporting of complaint files through review of daily complaint reports
  • Maintain and improve established coding guidelines to ensure consistency and accuracy with coding and reporting events
  • Verify that assessments of regulatory reporting requirements are accurate and in accordance with regulatory guidelines and product labeling. Collaborate and serve as clinical consultant with Post Market Vigilance, R&D, Quality, Risk Management and Regulatory groups to support appropriate reporting of adverse events to FDA, and other global competent authorities and regulators
  • Respond to inquiries from Regulatory Authorities
  • Respond to customer inquiries and complaints, assuring timely, accurate information given to patients, doctors, hospitals either directly or through support of PMV staff
  • Ability to understand and evaluate Engineering analysis of returned devices and compose conclusions based on this information while identifying significant issues and escalating where appropriate
  • Compose clinical conclusion to be included in the reports to competent authorities around the world
  • Identify safety triggers and unexpected serious harm events to determine severity of harm and appropriate escalation through completion of Complaint Trending Analyses
  • Investigates all escalated complaints involving serious injuries or death to assure safety of products and maintain compliance with regulatory agencies
  • Perform safety assessment for Distributed Product Risk Assessment, Health Hazard Evaluations/Health Hazard Analysis
  • Participation in Risk Management Board discussions by providing surveillance data analysis, severity assessment per risk management documentation and medical input
  • Provides surveillance data analysis, severity assessment and medical input into Quality Review Board meetings to support timely identification of potential field actions
  • Initiates communication and/or site visit with the field and customers as needed
  • Provides education and training of Cordis employees about anatomy, clinical applications and use of Cordis products
  • Perform clinical reviews and provide input of clinically related product risk issues during the development of the clinical portion of risk management documents such as FEA's, Risk Management Plan, Risk Management Report, Safety Surveillance Plan and Clinical Evaluation Report in support of new product development and regulatory requirements
  • Serve as clinical consultant for new and updates to product Information of Use to ensure appropriate safety standards, risk and precautions are included. Understands and able to compose Instructions for Use for class III medical devices
  • Responsible for communicating business related issues or opportunities to next management level
  • 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
  • Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance
  • Performs other duties assigned as needed

Education and Experience Requirements:
  • BSN or equivalent, Masters degree preferred (non-Nursing acceptable)
  • Hospital/clinical experience in cardiovascular/endovascular interventions or equivalent combination of education and experience
  • Experience in quality and patient safety or clinical risk management, knowledge of medical compliance standards, and regulations
  • Prefer experience in either clinical specialist, clinical education, quality improvement, or administration related to interventional radiology/cardiology
  • Complaint Handling experience preferred
  • Risk Management experience preferred
  • Post Market Surveillance experience preferred
  • Project Management experience preferred
  • People leadership experience preferred
  • Familiarity with IS Standards 13485, ISO 14971 as well as EU MDR 2017/745, MEDDEV 2.7/1, MDD 93/42 is preferred
  • Excellent written and oral English communication skills
  • Knowledge and proficient use of Microsoft Office Suite Applications and ability to navigate computer databases for complaint harm investigation is required
  • Strong work ethic, patient focus and commitment to serve internal and external clients
  • Proactive with a sense of urgency in managing job responsibilities
  • Energy, focus, motivation and debate-friendly
  • Analytical thinking and inquisitive mindset for instigations and problem solving
  • Team player, "Can-do" attitude and excellent interpersonal skills
  • Ability and desire to develop good working relationships internally and externally
  • Practice and share accountability with others for a positive team spirit characterized by mutual support of corporate culture, understanding, encouragement, and an active exchange of new ideas
  • Ability to travel once a quarter
  • ID: #39826924
  • State: Florida Miamigardens 00000 Miamigardens USA
  • City: Miamigardens
  • Salary: TBD
  • Job type: Full Time
  • Showed: 2022-04-29
  • Deadline: 2022-06-27
  • Category: Et cetera