KARL STORZ United States is currently looking for a Product Safety & Vigilance Specialist. This role is responsible for identifying, assessing, communicating, and developing action plans to address real or theoretical product safety risks. In addition, this person ensures compliance with regulatory standards and guidelines, and corporate standard operating procedures as they relate to the global medical device reporting and complaint management; ensures clear and balanced communication and processing of potential MDRs, in collaboration with European Headquarters and other internal and external stakeholders, as subject matter expert; and provides guidance and advice and works with regulatory agencies.

Responsibilities

• Participates in the investigation and assessment of potentially reportable events:

• Gathers, reviews, and analyzes data and documentation, performing product surveillance within North America for potential corrective action and continued improvement/product excellence.
• Reviews, evaluates, and interviews appropriate people regarding product complaints relative to the identity, quality, safety, and effectiveness of medical devices.
• Tracks and reports on all stages of the investigation process including data analysis, reporting, documentation review, coordination of complaints, device history reviews, compliance, and review and closure of complaints.

• Assist with upstream and/or downstream processes to obtain additional information:

• Coordinates activities required for investigations, including failure analysis, nonconformance, and corrective and preventive action (CAPA), working with Engineering, Manufacturing, and Quality Assurance.

• Ensure complete and consistent documentation of vigilance cases with timely processing to final closure:

• Documents the analysis of product complaints for trends and identification of potential corrective or preventive actions.
• Reviews and analyzes documentation and determines root cause or if there are any irregularities that may have related to reported product failures. Evaluates and determines risk of product failure.
• Develops proactive internal and regulatory risk minimization action plans for real and theoretical risks. Utilizes understanding of the scientific basis for diseases, adverse events, and knowledge of risk management tools to assess benefit versus risk.

• Participates in multi-site product safety teams and Field Safety Corrective Actions:

• Supports the developing of project plans and contributes to completion of milestones associated with specific product safety teams and FSCAs.

• Communicates with authorities and regulatory agencies on reported cases and market actions:

• Assists during FDA, ISO, or other third-party audits and implements or assists in implementing corrective and preventive actions.

Requirements

• 3-5 years' experience in a highly regulated environment - preferably medical device/pharma industries. Experience in Quality, Product Safety, Product Surveillance or Vigilance preferred.
• 4 year-degree or commensurate experience may be substituted for degree requirement. Completion of commercial training or medical training as a health care professional with administrative experience.
• Strong PC skills (MS Office, SAP/R3)
• High customer and service orientation
• Conscientious, reliable, and independent way of working
• Ability to work in a team and flexibility
• High communication and conflict resolution skills
• High sense of personal accountability and responsibility
• High communication and conflict resolution skills
• Solution-oriented

Preferences

• 5+ years of experience in a highly regulated environment

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