This position effectively supports the complaint handling process by assessing complaints in a compliant and timely manner, for Medical Device MDR / Vigilance reportability of adverse event(s) to the FDA and other National Competent Authorities in the countries in which Zimmer Biomet distributes products to. This position is responsible for decision making, preparation, creation and submission of initial, supplemental and final reports to US, European and International NCAs. Works with local RA/QA representatives on determination and filing of foreign incident reports. Prepares responses to standard and extended requests from Competent Authorities and provides guidance and feedback to other team members pursuant to the corporate and site specific procedures.
Principal Duties and Responsibilities:
Adheres to all corporate and site specific procedures.
Identifies and investigates solutions to procedure and process related issues. Revises procedures or processes as needed to increase efficiency and compliance.
Performs timely assessment of complaints to determine whether an adverse event report/Medical Device Reporting (MDR) is necessary in accordance with 21 CFR Part 803 Medical Device Reporting and 806 Corrections and Removals, Canadian regulations, European Vigilance Reporting (93/42/EEC) and any other worldwide regulatory requirements and documents the assessment in accordance with corporate and site specific procedures.
Accurately prepares, generates and submits initial, supplemental and final incident reports (e.g., MDR, MDV etc.) upon adverse events to US, European and International NCAs within the regulatory timeframes.
Generates and reviews the Alternative Summary Report (ASR) and Periodic Summary Report (PSR).
Prepares responses to standard and extended requests from Competent Authorities.
Works with local RA/QA representatives on determination and filing of foreign incident reports.
Monitors Medical Device Reporting metrics to ensure that the key performance indicators are being met.
Provides direction to internal and external personnel on issues related to product experience reporting, complaints and adverse event reporting.
Assists Product Surveillance Management in special projects as required.
Expected Areas of Competence (i.e., knowledge, skills and abilities):
¿ ¿ Strong organizational and time management skills.
¿ Strong written, oral, and presentation communication skills.
¿ Knowledge of EtQ, Internet, Microsoft Office applications and the ability to learn other software quickly as required.
¿ Ability to consistently meet high standards of input accuracy, produce quality documents, compile data, and perform simple analyses with accuracy.
¿ Strong decision making skills and proven ability in balancing priorities among the many ongoing tasks, and being responsive to critical situations, as this position has a high volume of work, regulatory mandated time limits, and often changing priorities.
¿ Action-orientated: Ability to take initiative to correct problems or make changes for improvement without waiting for direction.
¿ Proven ability to work in a team setting. Willing to share the load and participate in projects outside of normal job scope. Ability to work closely with others to assure functional commitments is met.
¿ Proven ability to provide training to Team Members as needed.
¿ Ability to work with all individuals in a congenial and cooperative manner.
¿ Bachelor of Science degree in biology, health sciences, engineering, or nursing preferred or Bachelor¿s degree in another discipline with equivalent years of relevant experience.
A little about us:
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