Director, Clinical Surveillance – Clinical and Medical Affairs-MED001872

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. DescriptionWe always strive for creating more value for customers and patients. Vital to these efforts is making successful clinical surveillance (e.g. clinical/performance evaluation reports and post market clinical/performance follow up). Join us in continually improving quality and our adherence to the MDR and IVDR regulations.

Management of 5 Clinical Scientists

Shaping the strategy, defining processes and people management is your main responsibilities. The current team members are quite new in the organization and have been part of our journey of developing our Medical & Clinical Affairs (C&MA) team. The team is responsible for writing the clinical/performance evaluation reports and post market clinical/performance follow up plans and other deliverables.You will be reporting to Senior Director, Clinical & Medical Affairs, Susanne Nickelsen.

Your responsibilities in short:

• Set the strategic direction and drive the plan to support the product areas throughout the product lifecycle within clinical compliance
• Leadership of 5 highly engaged associates
• Manage the regulatory requirements within clinical surveillance for all countries and product areas
• Ensure alignment with colleagues to define and execute strategies, cross functional plans and key deliverables for Radiometer's services and products
• Be a valued partner in the C&MA leadership team and ensure an optimal collaboration across C&MA
• Execute and communicate the C&MA strategy and identify areas for improvement
• Accountable for training of all associates in the Clinical Surveillance team
• Accountable for adherence to procedures ensuring compliance with standards and regulations
• Accountable for the delivery of high-quality deliverables in accordance with written procedures, current legal requirements and internal standards

Contribute 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 a high importance to everyone in our organization and that is why we have many employees building and developing their careers for many years in Radiometer and Danaher.

Application process

Application deadline is 2 December 2019. Start the application process by pressing "Apply Online" and follow the guidelines on our corporate career site. Please attach your CV and other relevant documents. We look forward to receiving your application.
For further information, please contact Senior Recruiter, Peter Høgh: [email protected]

Qualifications

• Academic scientific degree with many years of related work experience within the QA/RA/clinical compliance area with IVD, MDD or life science products
• Min. 4 years of people management
• Excellent knowledge and understanding of Clinical Surveillance and compliance and a good understanding of research as well as clinical trials
• Possess business oriented thinking, and can apply this without compromising the scientific elements of the work
• Proven ability to understand, integrate and communicate scientific/medical/clinical information
• Ability to build strong professional relationships internally and externally
• Structured and organized
• Strong analytical, strategic and communicative skills
• High ethical standards
• Able to communicate fluently in English, oral and written
• Good IT skills within PowerPoint, Excel, Word
• Travel estimated to max. 30 days pr. year

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: Science
Primary Location: EMEA-Western Europe-Denmark-Hovedstaden-Brønshøj
Schedule: Full-time

Kilde: Jobnet.dk