Regulatory Affairs Specialist // DepuySynthes in Zuchwil

Zuchwil, Solothurn
Nadja Schuler, Randstad JnJ HQ
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Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. We have more than 265 operating companies in more than 60 countries employing approximately 127,100 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.

DePuySynthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuySynthes Companies will offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today?s evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.

Main Responsibilities:

  • Support the internal Regulatory Affairs group in creation and maintenance of Technical File documentation according to Council Directive 92/42/EEC:

  • Creation, review and maintenance of regulatory related technical documentation

  • Capturing and verification of regulatory product characteristics to support logistic and supply chain efforts on a global scale

  • Providing Regulatory input and support for upcoming MDR revision


  • Commercial apprenticeship or higher

  • 2-3 years? experience in European Medical device industry especially with regulatory, quality or engineering

  • Profound knowledge of European Medical Device Regulations, especially Council Directive 93/42/EEC desirable

  • Knowledge of FDA regulations and registration requirements in further global markets would be an asset

  • Familiarity with Technical Documentation structure according to STED required

  • Experience in projects related to Supply Chain and Logistics is a plus

  • Excellent skills in computer software such as MS Word, Excel, Powerpoint

  • Strong Database skills

  • Strong analytical skills and network thinking

  • Excellent English spoken and written, German is an asset

This role based in Solothurn, Switzerland will initially be limited until 31st August 2018. If you are interested in working for a global leading health care company in a challenging role, then use this entry level position and send us your application in English today to Or give us a call if you have any questions!

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