Regulatory Affairs Coordinator // DepuySynthes in Solothurn

veröffentlicht
Kontakt
Nadja Schuler, Randstad Inhouse Services J&J Zug
Jobtyp
Temporary
jetzt bewerben

job details

veröffentlicht
Ort
Solothurn
Sektor
Administration
Jobtyp
Temporary
Referenznummer
138873-131
Kontakt
Nadja Schuler, Randstad Inhouse Services J&J Zug
Telefon
058 231 52 20
jetzt bewerben

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:

As support to the EMEA Regulatory Affairs Lifecycle Innovation (RALI) Department, this role is responsible for administrative activities to ensure registration information in tracking systems is accurate and current.

This individual will support the RALI Regional Portfolio Leader for EMEA with the compilation, data entry and tracking of regulatory information specifically associated with change impact assessments, registration submission planning and submission tracking across multiple business units for countries supported by RALI, with responsibilities including:

  • Providing regulatory information upon request from international affiliates
  • May be requested to prepare requested documents for product registrations
  • Coordinate data collection, entry and monitoring in the Trackwise system, including follow-up with Local Operating Company colleagues
  • Maintain databases (Trackwise and MDRIM)
  • Organize, file, and archive regulatory data/documentation
  • Post documents on internal SharePoint and/or web sites
  • Researches and collects information and data for reports

Qualifikation

Who we are looking for:

  • Commercial apprenticeship or higher
  • 1+ years’ experience in European Medical device industry especially with regulatory, quality or engineering would be an asset
  • 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
  • Strong ability to pay close attention to detail
  • Ability to communicate clearly
  • Excellent English spoken and written, German is an asset

This role based in Solothurn, Switzerland will initially be limited until the end of the year, with an option for extension. 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. Or give us a call if you have any questions!