Manager R&D, Verification & Validation-MED000079

RADIOMETER MEDICAL ApS

København, 1 stilling

Description



This is a great opportunity for an innovative manger, who appreciates fast-paced environment with focus on development and personal influence.



You might be working currently on a similar position and dreaming about career in an international company that is leading in the sector.



As a Manager for verification and validation you will be a part of the R&D ABL90 management team and you will have an impact on the verification and validation activities on the ABL90 platform. We are looking for a strategic person that can execute tasks to meet design and registration requirements and secure that we obtain the product registration needed – especially FDA approvals.





The job



The work is related to ABL90 Flex family, new features and quality improvement. New parameters will be added in the future and the next generation platform is on its way getting ready for verification and validation. A huge part of the job is planning and strategy for device approval - especially FDA approvals but in the future also increasing requirements from CE countries and China.





To become successful in this position you need to be attentive to details while seeing “the big picture” at the same time.





Your main responsibilities and tasks will include:



•Planning, executing and finalizing System validation activities with focus on Clinical trials and FDA approvals

•Planning, executing and finalizing System verification activities

•V&V strategy and planning

•ID processes for validation improvements and initiating activities to execute

•Handling TM/DHF requirements

•Focusing on TG2 to TG5 deliverables and activities

•Coordination of internal and external stakeholders

•Managing and developing a team of 4-5 associates (combined lab techs and chemists)





Qualifications



"Constructive Diversity" is one of our core values, and we believe that human diversity creates a dynamic and creative environment. Therefore, we encourage diversity through our recruitment process. However, we believe that the following formal qualifications will improve your chances of success:



•MSc Degree in Analytical Chemistry, or Biochemistry,

•3-5 years of experience in managing white collars,

•Experience within Medical Device

•Good knowledge of Quality System Requirement

•Minimum 5 years of experience with Verification & Validation especially FDA/510K approvals

•Solid experience with project management (including responsibility for people resources)

•Good track of records with leading people

•Fluent English written and oral

•Knowledge of Danish would be a benefit





As a person you must be focused, passionate and committed about what you do, as well as:

•Proactive – showing initiative and driving for results

•Analytical and with an eye for details

•Stress-tolerant – able to stay organized and systematic even in very fast-paced environment

•Team-oriented





Interviews will be held as soon as relevant candidates have been identified



...so please do not hesitate to apply. Start the application process by pressing "Apply" and follow the guidelines on our corporate career site. Upload your CV and other relevant documents. Please bring diplomas for face-to-face interviews. We are looking forward to receiving your application. Please observe that the deadline for your application is 31 May





We offer you



A unique opportunity to work in the field of medical technologies, where knowledge sharing and professional respect combine to make it both fun and meaningful to go to work. Both in Denmark and abroad you will meet enthusiastic colleagues who take pride in making a difference in a company whose products can truly impact other people's lives. We offer you 'freedom with responsibility', opportunities for training and career development, and a wide range of staff benefits.





For further information, please contact Carsten Aagaard Andreasen, Head of R&D, ABL Point of Care at tel. +45 2169 1698





Make an impact on life



The difference between life and death can be just a few minutes. Radiometer’s diagnostic equipment is of crucial importance to doctors all over the world in their effort to diagnose critically ill patients quickly and accurately. From biotech and software specialists to financial controllers and engineers, all 2500 colleagues are committed and dedicated in their effort to make an impact on the life of others with our high-quality solutions. Radiometer’s leading position in the market has been secured over the last 50 years. Together we continue to raise the bar in acute care and constantly develop in new areas. Radiometer has an annual turnover of more than DKK 3 billion and is owned by US-based Danaher Corporation.





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. A globally diverse team of 71,000 associates, we are united by our culture and operating system, the Danaher Business System, which is our competitive advantage. In 2014, we generated $19.9B in revenue and our market cap exceeded $60B. We are #149 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 2,000% over 20yrs.



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.





Organization: Radiometer

Job Function: Research and Development / Scientific

Primary Location: Europe-Denmark-Hovedstaden-Brønshøj

Schedule: Full-time