Are you good at navigating in organisations, scouting for knowledge and data? And do you enjoy data analysis and transforming it into clear PMS reports?
Right now, we are searching for a Post Market Surveillance (PMS) Specialist, a newly established role placed in our Quality Function area in Demant.
As a manufacturer of medical devices, we are operating in a highly regulated market and therefore subject to several relevant requirements. One of these are the preparation of Post Market Surveillance (PMS) reporting – an important part of the regulatory framework for medical devices in Europe. The aim of PMS system is to actively and systematically gather, record and analyze relevant data on the quality, performance and safety of medical devices throughout their entire lifetime. This allows us as a manufacturer to continuously update the risk-benefit assessment and to initiate necessary measures without delay.
About the job
As our PMS Specialist you are responsible for – and have full ownership of the PMS data collection, processes (SOP), and templates, leading to high quality and compliant PMS reporting. The data for the reporting comes from all parts of the company and some data are transferred directly as relevant documentation in the PMS report, and in other cases you are required to analyse the data and summarize on the results and conclusions. Strong planning and stakeholder management is a must, and keeping deadlines for PMS plans, reports and summary for the EUDAMED database is crucial.
Your key responsibilities
- Continuously optimizing the Standard Operating Procedures, instructions and templates for the PMS area
- Gather data across the company
- Represent the process and trending procedures of the PMS area during internal and external audits
- Report on Class 1 and Class 2 Products
- Work out plans for PMS reporting
- Safeguard schedules and deadlines for publishing plans and reports (e.g., in EUDAMED)
- Keep a focus on health and safety
- Expand the PMS area if relevant and needed
- Improve and automate data gathering and reporting methods
- Support colleagues in the Data analyst function on reporting in special need situations
Qualifications & experience required
First and foremost, you are an experienced data analyst, that know your “corporate ropes” for data collection and reporting. Secondly, as you will be collecting data across the company you have to be skilled organizational navigator making your key stakeholders “work for you”. Meaning, – providing all the data you know you need – in time – but also the data you did not know you needed. In short – you must be an excellent stakeholder manager – respected for the way you lead the PMS area and appreciated for the person you are.
- have experience with the regulatory area from another Medical or MedTech company
- comes from a similar position or have experience with the described job responsibilities from a QA function
- understand the depth of the data you are collecting as you quickly acquire new knowledge about products and product structures
- have technical understanding and interest
- are an engineer by background (not a must)
We dare to make a difference
Together with your ambitious and talented colleagues, you will be part of a dynamic environment built on trust and openness, where you will find a strong will to win. We are a growing international company, where everyone strives to ensure that customers find our products the most attractive on the market. You will become part of a work environment where flexible working conditions, knowledge-sharing and professional respect make it both challenging and meaningful to go to work.