Työnimike: Regulatory Affairs Manager

Työnkuvaus:
About Us: KaVo Kerr Group is the world leader in smart products and processes that enable dental professionals to confidently optimize their work and lives. KaVo Kerr Group Tuusula site, previously known as Palodex Group Oy, is one of the leading R&D and manufacturing centers of excellence for dental imaging equipment and solutions in the world. Our imaging brands are recognized and renowned players in the field since decades. KaVo Kerr Group Tuusula site's turnover is approximately EUR 130 million and we employ about 400 people. Exports account for 99% of our turnover. Today we are a part of global Danaher Corporation, listed at NYSE. Our roots are firmly in Finland and Finnish imaging knowhow. Being a part of a multinational market leader provides our operations with a springboard for further expansion and success. Job Description: The Regulatory Affairs Manager's primary responsibility will be to obtain regulatory approvals to sell our products in countries throughout the world. Other duties would center around the research, understanding and communication of regulatory requirements throughout the organization to ensure products and processes comply with all required standards. The Regulatory Affairs Manager is responsible for the preparation and submission of documentation to support compliant market entry including FDA 510(k) submissions. The RA Manager is also responsible for managing the International Product Registration process and to author formal communications with regulatory agencies. You have excellent problem solving and presentation skills, fluency in English, as well as the ability to learn a new environment quickly. You will identify, communicate and implement the key priorities to the organization with little guidance or direction and exercise judgment to determine sense of urgency for priority. You have proven ability to manage multiple projects in a matrix team environment. Qualifications: You have M.Sc or B.Sc degree in an engineering and minimum 5 years' experience in Regulatory Affairs including experience with FDA 510(k) submissions. Understanding of device design documentation is important. Experience in Quality Control setting with FDA regulations and/or ISO standards (FDA's CFR 21, ISO 13485) the European Medical Device Directive (93/42/EEC), and the Health Canada Medical Device is preferred. We offer you interesting challenges in a growing global business, and an opportunity to work with top-quality imaging systems as part of a highly professional team. Interested? Please submit your application and CV with salary request to our recruiting system at latest on 30.4.2016. We are constantly going through new applications and the best candidates will be asked to the next step of the recruitment process already during the application period, so if you want to join us act now! 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 81,000 associates, we are united by our culture and operating system, the Danaher Business System, which is our competitive advantage. In 2015, we generated $20.6B 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. For further information, please visit www.danaher.com

Työnantajan nimi: PaloDEx Group Oy

Työnantajan osoite: Nahkelantie 160, 04300 TUUSULA

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Työn lyhyt kuvaus:
Teollisen valmistuksen ja tuotantotekniikan erityisasiantuntijat

Maa: Suomi

Alue: Helsinki-Uusimaa

Sopimuksen kesto: Tilapäinen

Sopimuslaji: Kokopäiväinen

Kokea: Yli 5 vuotta

Lähde työtarjous:
MOL/Työ- ja elinkeinoministeriö, Julkiset työvoimapalvelut, Suomi