Post-market Surveillance Specialist-MED001850

About Us

At Radiometer, our mission is to help caregivers make diagnostic decisions that save lives. To provide caregivers the insight and confidence that help them arrive at the right diagnostic decisions – decisions that in the end help save lives.

On a yearly basis millions of lives are touched by the information our solutions provide and that’s a fact, we take very seriously; the more critical the setting, the greater the requirements are and that’s why we’ve made it our vision to improve global healthcare with reliable, fast and easy patient diagnoses. Want to know more about our mission and vision? Click on the link: Link of YouTube video

Our people

At Radiometer, we acknowledge that the information our products provide is often the difference between life and death; an acknowledgement that drives and unites us as a company. From biotech and software specialists to financial controllers and engineers, all 3800 colleagues are committed and dedicated to help realize life’s potential.

If you aspire to be part of a purpose, performance and values driven organization whose mission and vision guide every action, we are eager to hear from you. DescriptionIf you have experience within Post Market Surveillance, Vigilance, R&D or Customer Complaints please have a look at what we have to offer in this job. We are preparing to report according to the new EU medical device regulation in May 2020 and we need you to be a part of our team to ensure surveillance of our products’ performance in the market.

Looking at product performance and quality through cooperationYou work with creating templates, collecting and analyzing data and finally, reporting to health authorities and to Radiometer Medical’s management. While working independently with reporting it is possible to exchange best practices with the highly experienced and helpful members of the team.

Collaboration is key as you facilitate meetings with contributions from our colleagues in RA / Vigilance, QA Customer complaints, R&D, Operations and Marketing. Together you problem solve and figure out if and why a product has not performed to the customer’s expectations. Discussing the countermeasure and follow-up actions is essential as you keep track of trends and what is needed to escalate internally or externally.

Contributing to regulatory compliance as well as excellent post-market surveillance reporting gives our colleagues better input on how to improve our products and ultimately help our patients.


The team

You join a newly established and growing team of highly skilled and engaged colleagues. The Surveillance team has a significant cross-functional role in Radiometer Medical both in Denmark and on a global scale. We collaborate across production sites, subsidiaries and headquarters in order to succeed in finding simple and effective solutions for excellent post-market surveillance reporting processes.
Our team has a talent for great stakeholder management, for creating good relations and for facilitating improvement.


Your responsibilities

You take on the newly established role as a specialist focusing on medical devices and in vitro diagnostic devices according to the MDR/IVDR coming into force 2020/2022. Your first challenge in the job is to:
• Establishing and standardizing data collection in Radiometer Medical globally according to MDR/IVDR
• Set up the processes for analyzing and assessing post-market surveillance data consistently across all products
• Establishing a statistical framework utilized in the assessment
You can look forward to building relations with multiple stakeholders including RA/QA, Operations, Global Marketing, Global R&D and Global Sales. We estimate your travel activity can be around 5 % of your time.


Contribute, grow and develop

Radiometer is a growing organization always developing through LEAN management tools and values. It makes it fun and meaningful to be part of an organization where your thoughts and ideas are embraced by management and can make a true impact. Developing on a personal and professional level is of high importance for everyone in Radiometer and that is why we have many employees building and developing their careers for many years in Radiometer and Danaher. ¨

The application deadline is 18 November 2019

Start the application process by pressing "Apply Online" and follow the guidelines on our corporate career site or apply quick and simple through LinkedIn. We look forward to receiving your application.
For further information, please contact hiring manager Lisbet Bærentzen [email protected] or Senior Recruiter Peter Høgh, [email protected]

Qualifications

We believe that a background as engineer, biologist or similar with post-market surveillance reporting, vigilance or customer complaints experience will be a valuable asset in the job as well as:
• More than 5 years’ of experience from working with compliance within the pharmaceutical or medical device industry
• Proven track record handling complex data analysis and statistics
• Excellent business acumen
• Excellent knowledge of and experience driving constant improvements
• Strong communicator for all levels of the organization

Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.

Organization: Radiometer

Job Function: Marketing

Primary Location: EMEA-Western Europe-Denmark-Hovedstaden-Brønshøj

Schedule: Full-time

Kilde: Jobnet.dk