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

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

Languages:

• Fluent English, any additional European language is a plus