Regulatory Affairs Specialist

  • Full-time

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, geopositioning 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.

 

Job Description

The Global Regulatory Affairs (RA) department coordinates the activities of all Topcon regulatory affairs team business.

This global function sets the RA strategy for the corporation, collecting changes in the RA landscape, evaluating the impact on the corporate business, and developing strategies to implement these changes.

Besides giving guidance on RA matters to all other functions within Topcon.

The candidate will be mainly in charge for coordinating marketing authorizations to US FDA and serving as the main contact point for the corporation for all issues related to US FDA regulations and policies.

Qualifications

  • Main tasks
    • Develop approval strategy for product marketing in the USA (Class I, Class II, and De Novo)
    • Focus on active medical devices and Software (SiMD, SaMD)
    • Support of Clinical Trials team in the US (Protocol development, CSR, statistics, etc.)
    • Prepare 510(k) dossiers for FDA approval
    • Review 510(k) dossiers
    • Train colleagues on FDA regulations, policies, and FDA submission documentation requirements (worldwide)
    • Coordinate all activities with the US team to incorporate up-to-date information and requirements from FDA
    • Conduct internal trainings on RA requirements
       
  • Profile
    • MSC in Engineering, Science or related discipline required
    • Experience in the US approval process (3-5 years)
    • Minimum 10 successful submissions (510(k))
    • Experience with the approval of software with a focus on cybersecurity desired
    • Experience in ophthalmology / optics preferred
    • Deep knowledge of the common regulations and standards
      • FDA 21 CFR 800, Regulation 2017/745 (MDR), IEC 62304, IEC 60601-1 Clause 14
    • Knowledge of ISO 13485 and MDSAP are preferred
  • Misc:
    • Very good communication skills in an intercultural environment
    • Good English skills
    • Willing to travel internationally (20%)

Additional Information

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