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Post Market Surveillance Specialist

Företag GN Group


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Post Market Surveillance Specialist

GN is a global leader in intelligent audio solutions that let you hear more, do more and be more than you ever thought possible. The surveillance of our product quality and market feedback is important for our business. Our new colleague is going to contribute to logging our complaints and gather input for vigilance reporting by collecting feedback from customers and colleagues globally.

Welcome to our Vigilance and Post Market Surveillance team

We are a small close and friendly, who are liked and known for our ability to bring important insights into our product quality. We believe in developing as people in our team, allowing the flexibility for work life balance and creating a nice and engaging workspace.

What you will be doing:

Your most important task is to help manage safety related complaints including MDR/Vigilance reporting within applicable deadlines. We do not have many complaints to handle and from a clinical perspective you will be assisted by your manager and more experienced colleagues in this area. Understanding our recall procedures and being the Superuser for potential safety and vigilance aspects is also part of your operational tasks.

You will lead and facilitate PMS activities in accordance with relevant global regulations to support our products regarding safety and performance. Interaction with a wide range of stakeholders - and here especially with Development, Customer Support, Product Management, Global Sales, Resellers, and external consultants worldwide – does in addition characterize this role.

  • Ensure that the PMS requirements for our products comply with current and future global medical device regulations, including the EU Medical Device Regulation (MDR)
  • Contribute to continuous improvement of PMS processes and procedures and conduct training as appropriate
  • Collect and interpret relevant PMS data from multiple stakeholders, including writing PMS plans, PMS reports, and Periodic Safety Update Reports
  • Provide a clinical safety and usability perspective to the overall Risk Management Process and individual Product Risk Assessments
  • Interact with authorities to fulfill the regulatory requirements related to PMS, Vigilance, and Trend Reporting (e.g., reporting of serious incidents and Field Safety Corrective Actions)
  • Support the organization during internal and external Audits
  • Support decision making with qualified data within the areas of key responsibilities, including data on issues to be escalated to Corporate Quality management.
  • Support decision making with qualified data within the areas of key responsibilities, including data on issues to be escalated to Corporate Quality management.
  • Handling potentially-/safety related complaints and associated vigilance reporting,
  • Establish frequent communication with relevant stakeholders within GN supporting the timely handling of potential safety related complaints and vigilance reporting
  • Monitor, trend and analyze potential/safety complaint data on a high-level
  • Report monthly on Quality Performance Measures related to vigilance reporting
  • Responsibility for the global Vigilance Reporting and Recall Procedure and any necessary updates in the future.

Background and qualifications expectations

We imagine that there can be several ways of contributing meaningfully to this role. Overall, we expect you to be interested in Quality, systems, complaints and vigilance. Formally, we expect that the following will increase your chances of success:

  • Audiology background or a Master’s degree within a scientific field and preferably a Ph.D
  • Any experience with quality systems in the Medical Device Industry
  • Any experience from working with Customer Complaints or Vigilance
  • Experience with scientific writing and audit/inspections
  • Knowledge of Medical Devices and related standards like ISO 13485 and MDR
  • Excellent planning, cooperation, and communication skills
  • Experience in scientific or regulatory writing

What we offer

Our workplace offers plenty of different benefits and flexibility to keep us happy and healthy and allow us to focus on what matters to us in and outside of work.

We hope you are curious to explore and engage in the recruitment process with us.

How to apply

To apply, use the ‘APPLY’ link and please upload your CV.

We look forward to hearing from you.

Dela detta jobb

Post Market Surveillance Specialist

GN Group