regulatory affairs specialist // depuy synthes in solothurn

posted
job type
temp to perm
apply now

job details

posted
location
solothurn
job category
Life Sciences
job type
temp to perm
reference number
138873-157
phone
058 231 52 20
apply now

job description

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.

DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes 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:

Responsible for supporting activities that initiate and maintain international product approvals for Global Orthopedics.

  • Providing documentation to support international registrations and tender requests
  • Preparing responses to questions and requests from health authorities for product registrations
  • Submission of requests for Certificates of Free Sale, legalization and notarization of documents
  • Ensure compliance with regulatory agency regulations and interpretations
  • Provides solutions to a variety of problems of moderate scope of complexity
  • Maintaining and archiving all regulatory documentation

qualification

Who we are looking for:

  • B.A./B.S. Degree preferred or equivalent work experience
  • 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
  • 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 to approx. 12 months, with the option for an 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!