Post Market Surveillance Specialist

Oticon | Posted 23-02-2021

Smørum (Database)


Post Market Surveillance Specialist

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.


Further, you:


  • 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.


Want to join us?

Kindly submit your application as soon as possible, as we are screening applications on a continuous basis. Deadline for the application is March 3, 2021. We only accept applications via our online recruitment system please contact Head of Complaint Management, Per Bernack +45 51 24 52 26 or email to pber@demant.com


We look forward to hearing from you.


Make a true difference!

By joining the Oticon team, you help bring sounds to the millions of hearing impaired all over the world so they can live natural lives with friends and family.

You will find the perfect framework for your professional and personal development in a culture built on trust, openness and mutual respect. We welcome you in a growing international company where we push hard to be at the forefront of what is technically possible. No matter if the goal is a new, highly advanced hearing aid feature, a new ERP system or a totally revolutionary marketing tool, we strive to excel.

We are very proud of our company, our products and our unique culture. But don’t just take our word for it. In 2020, for the fifth year in a row, “Ingeniøren” (the Engineer) has awarded us the number one employer within electronics and telecommunications in Denmark. Want to join us?


About Oticon

500 million people worldwide suffer from hearing loss. It is Oticon's ambition that our customers - hearing clinics throughout the world - prefer to use our products for people with impaired hearing. Oticon is one of the two largest companies in the industry, and in Denmark all 1,600 employees, with passion, dedication and professional expertise, develop some of the most innovative hearing aids in the world. Oticon is an international growing company, and 98% of Group revenues is generated outside Denmark. We are part of the Demant Group with more than 15,000 employees and revenues of more than DKK 15 billion.