Regulatory Affairs Specialist // DepuySynthes in Solothurn

veröffentlicht:
Ort
Solothurn, Solothurn
Sektor
Life Sciences
Jobtyp
Temporär
Referenznummer
138873-108
Kontakt
Nadja Schuler, Randstad JnJ HQ
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Stellenbeschreibung

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:

  • Providing support for Wave 2b and 3 market registrations and license renewals
  • Providing documentation to support international registration and tender requests
  • Preparing responses to questions and requests from health authorities for product registrations
  • Managing a significant amount of proprietary information in a confidential manner to prevent loss of intellectual property
  • Ensuring compliance with regulatory agency regulations and interpretations
  • Providing solutions to a variety of problems of moderate scope of complexity
  • Maintaining and archiving all regulatory documentation

Qualifikation

  • Commercial apprenticeship or higher
  • 2-3 years experience in European Medical device industry especially with regulatory, quality or engineering
  • Knowledge of Medical Device regulations and registration requirements in further global markets would be an asset
  • Ability to work both independently and in a team environment
  • Ability to problem solve, recognize and find solutions for gaps in processes
  • Excellent skills in computer software such as MS Word, Excel, Powerpoint
  • Strong organizational and project management skills
  • Ability to communicate clearly
  • Excellent English spoken and written, German is an asset

This role based in Solothurn, Switzerland will initially be limited to approx. 12 months. 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 nadja.schuler@ch.randstad.com. Or give us a call if you have any questions!

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