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Regulatory Affairs Assistant

Company Description
We at Topcon are a global leader in the development and manufacturing of technology designed to address society's greatest challenges in eye health, agriculture, and construction. We specialize in integrating optical, mechanical and electronic technologies serving medical, construction, geo-positioning and agriculture industries. We are pioneers and innovators who are passionate about developing solutions that improve and enrich people's lives. We operate through a global network of 93 companies made up of subsidiaries and affiliates. We have over 4,900 employees worldwide. Our Medical Division is specialized in Eye Care.

Topcon Healthcare sees eye health differently. Our vision is to empower providers with smart and efficient technologies for enhanced patient care. Keeping pace with the ever-changing landscape of the healthcare industry, we offer the latest integrated solutions including advanced multimodal imaging, vendor-neutral data management and groundbreaking remote diagnostic technology.   A globally-oriented business, Topcon is focused on developing solutions towards solving societal challenges in the mega-domains of healthcare, agriculture, and infrastructure. In healthcare, these challenges include increasing eye disease, rising medical costs, access to healthcare and physician shortages. By investing in value-driven innovations, Topcon works to enable people to enjoy good health and a high quality of life.

The role:
The RA team assists in obtaining and maintaining regulatory approvals and ensuring that the products are manufactured and distributed in compliance with the appropriate legislation.  The RA team is a link between Topcon Europe Medical B.V. and the regulatory authorities in the EMEA region.

Administrative tasks :

  • Organize legalizations of documents
  • Order Free Sales Certificates
  • Arrange meetings (Local and Global) and travels
  • Support the team  with creating Presentations
  • Coordinating translations of manuals DOC’s / maintenance Translation log

Regulatory affairs tasks :

  • Supporting country registrations
  • Moderating Global Working Groups
  • Act as Back Up for the RA team
  • Monitoring the regulatory landscape in the EMEA region

Qualifications:

  • HBO or higher
  • Basic knowledge in MDD/MDR and international regulatory requirements is a pre
  • Knowledge of Office programs / Excel, MS Teams / ERP systems 
  • Willingness to “roll up sleeves” to perform at all levels and assist in areas outside of core responsibilities
  • Strong analytical skills and thinking
  • Team player in a global team
  • Excellent written, oral, and presentation communications skills in Dutch / English.
  • Strong resilience

What we offer you :

A challenge in an international environment, an informal work atmosphere where intrinsic motivation and initiative  is highly valued.

  • Employee premium free Pension 
  • 13th month  paid in December
  • 8% holiday allowance
  • 28 holidays per annum
  • Standard work week of 40 hours / Flexible working hours with block times from 10.00 to 16.00 hrs.
  • Training on- the- job possibility

IMPORTANT:
This role is based in Capelle aan den IJssel, Netherlands, applications from countries outside of EU which need a Visa/work permit will not be considered

More information about Topcon Europe Medical B.V. you can found on our website. https://topconhealthcare.eu/en_EU

Please apply here