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SENIOR SPECIALIST POST-MARKET SURVEILLANCE & MEDICAL LIAISON (GERMANY)

24/1/2023

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This role is responsible for the coordination and execution of Post Market Surveillance activities aligned with global regulations with a focus on the EU Medical Device Regulation (MDR). The position is to be located in Frankfurt cm Main, Germany.
Job Description
  • Perform medical assessment of complaints to support vigilance reporting. 
  • Decision making regarding reportability to the Competent Authorities. 
  • Ensure assigned regulatory tasks are completed accurately and in a timely manner while maintaining compliance to internal standards/procedures and applicable external industry regulations. 
  • Perform high-level post-market surveillance activities and projects associated with global regulatory compliance, and quality improvements.

Key Duties & Responsibilities

  • Create Periodic Safety Update Reports, Post Market Surveillance Plans/ Reports in line with defined process(es) and schedules
  • Coordinate the gathering of the necessary data to create the plans and reports
  • Evaluate the data received to ensure it meets defined parameters and organizes the data into the plans and reports. 
  • Develop relationships with key internal and external customers to identify, facilitate strategize, and prioritize the necessary activities to meet the business objectives. 
  • Support Post Market Surveillance meetings. 
  • Perform medical review of complaints in EMEA regions and when needed Globally and make a decision about reportability to the Competent Authorities
  • Create performance reports, metrics, and system reports surrounding Medical Information inquiries.
  • Maintain an in-depth understanding and strong knowledge of the product portfolio
  • Provide project support / vendor management for management of global medical monitors. Maintain relationship with medical monitors and consult when needed.
  • Review of PMCF study report evaluations, CER’s and ensure the reports are documented with the required technical information and coordinate activities with PMS documentation (PMS plans, PSURs etc.) 
  • Provide the feedback regarding the updates to the labelling of products
  • Assist in the development and execution of associated department procedures and work instructions. 
  • Assist in the development, planning, and delivery of training to staff and other teams to ensure efficient processes and compliance to regulatory requirements.
  • Initiate or participate in various continuous improvement projects that lead to the development of robust processes 
  • Assist in the preparation and hosting of company audits and compose written responses to any audit findings, as assigned.

Skills and Competencies

  • Graduate of Nursing/Doctor degree from a college/university in ophthalmology
  • Minimum 3-5 years of medical experience in ophthalmology area
  • Industry experience with Class II/III implantable medical devices preferred
  • Knowledge of Clinical Research practices and Requirements
  • In-depth knowledge of EU MDR 2017/ 745, ISO 13485:2016, FDA 21 CFR part 7/806/820, Vigilance (MEDDEV)
  • Experience with PMS activities and vigilance activities
  • Real World Evidence experience is highly desirable
  • Strong analytical and critical thinking skills with the ability to make sound judgments based on objective data and acquired knowledge
  • Excellent writing/composition skills with the ability to construct clear and comprehensive clinical/technical narratives
  • Solid knowledge of eye diseases, ophthalmologic surgical procedures and technologies 

Languages
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  • Fluent English, any additional European language is a plus

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