Rotate Device

Job Openings

Senior Specialist PMS and Medical Liaison – Ophthalmology (d/f/m)

Quality Assurance

Frankfurt am Main

Job Description

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). 

  • Perform medical assessment of complaints to support vigilance reporting. 
  • Decision maker about 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 schedule for all HOYA product lines.
  • Coordinate the gathering of the necessary data to create the plans and reports for all HOYA product lines. 
  • 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 HOYA’s products.
  • 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 labeling of HOYA’s 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
  • Minimum of 2 years’ experience in an Ophthamology clinic
  • 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 is desired


  • Fluent English, any additional European language is a plus


By submitting your application, you agree that your personal data will be collected, disclosed, and retained by HOYA Group for assessing suitability for employment and verification purposes. For more information about the processing of your personal data, please refer to our Privacy Policy, which can be found here.


We regret to inform you that only shortlisted applicants will be notified. Thank you for your kind understanding.



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