stillingsbetegnelse: Manager R&D, Verification & Validation-MED000079

jobbeskrivelse:
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

Arbejdsgiver Navn: RADIOMETER MEDICAL ApS

Arbejdsgiver telefonnummer: 38272829

Job kort beskrivelse:
Arbejde inden for biologi, botanik, zoologi og beslægtede områder

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark