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Fujirebio Diagnostics AB is looking for a Product Development Director based in Gothenburg
About Fujirebio Diagnostics
Fujirebio is a global leader in the field of IVD testing with more than 50 years’ experience in the conception, development, production, and worldwide commercialization of robust IVD products. The products span the range from specialized testing to fully automated routine clinical laboratory testing solutions covering a variety of disease states.
The company is looking for a Product Development Director (PDD) who will be responsible for managing and leading the R&D team of 20 highly skilled professionals within Product Development.
The PDD is a major contributor to the R&D strategy of the company and bear responsibility for steering product innovation and new product development in the field of in vitro diagnostics (IVD). S/he is responsible for completing the development of products on various instrument platforms and for managing the design transfer to manufacturing.
The Product Development Director reports to the Managing Director and is a member of the Management Team.
This is an office-based role with expected presence at the office 3 days/week so preferably you live in the Gothenburg area.
· Contribute to the business strategy and Management Team discussions from Product/Platform/Technology Development perspectives.
· Monitor competing and complementary technologies and keep abreast of latest in-market technological changes or novelties in the field of in vitro diagnostics.
· Formulate and implement the long-term strategy with respect to new and emerging technologies that advance company objectives.
· Support the identification, monitoring and, in close collaboration with business development, the licensing/acquisition of new technologies that can be incorporated into the company’s current and future products.
· Be a result-oriented leader and influencer with a proven track record in successful IVD product development.
· Plan, execute and organize all product development activities.
· Oversee initial feasibility studies and development activities under the Quality Management System following company’s Design Control Process.
· Interact with the Operations teams to ensure an on time and smooth transition from R&D into a manufacturing and supply environment.
· Work closely with Quality Assurance and Regulatory to enable successful regulatory filings in Europe (IVDR) and/or US (510(k)/PMA) or other parts of the world.
· Identify 3rd parties for potential collaboration and/or service rendering new business opportunities.
· Attract, develop, and retain top talent for the R&D function, while motivating staff to continually improve its performance.
· Fluent in speaking and writing in English and good knowledge of Swedish.
· Master’s Degree or PhD related to Life Sciences
· Broad technology knowledge and experience in development of immunoassay based IVD products.
· Must possess leadership skills, both strategic and analytical as well as in people Management
· Experience in Project Management
· International outlook and culturally aware
· Solid understanding of international business with market knowledge on industry trends in Diagnostics
· Strong technical and business mind and should be able to visualize future Product Development strategies while also outlining and driving tactics to complete the milestones to successfully execute that strategy towards launch of new products and applications to market.
· Commercial awareness and ability to bridge technology with market.
· Proven experience and understanding of finance principles from a business management perspective.
For more information, please contact;
Nina Fredriksson, +46 73 243 87 02, firstname.lastname@example.org
Anders Larsson, Partner +46 73 203 46 91, email@example.com
Adina Lekberg Salamon, +46 73 974 43 34, firstname.lastname@example.org
We meet candidates on an ongoing basis, so if you are interested in the position, we look forward to receiving your application as soon as possible.