(Junior) Regulatory Affairs Specialist

Dept./Div. European Medical Systems Division

Company Name: FUJIFILM Deutschland
Date: March 20, 2017
This position will need to support FUJIFILMs medical business in the area of x-ray, soft-
ware, IVD and endoscopy medical devices.
For the European Medical Systems Division we are looking for a (Junior) Regulatory Af-
fairs Specialist (m/f) for Medical Devices

Tasks:

- Represent the (medical) Regulatory Affairs function and provide regulatory guidance
and strategy to our mother companies and give European wide regulatory support for
FUJIFILM entities and dealers
- Act as medical regulatory contact person for European (but especially to German)
Competent Authorities, external partners and in-house functions
- Act as Safety Office for medical devices and organizing incident reorting and execution
of FSCA for FUJIFILM
- Keep current with European regulatory environment
- Participate at industry associations and organizations (pre & post CE mark)
- Act as auditor for FUJIFILM suppliers and dealers
- Giving trainings to FUJIFILM entities/staff
- Report to FUJIFILM worldwide headquarters

Qualifications:

- Degree in engineering, law, chemistry, biology, medicine or related discipline or equiva-

lent combination of education and experience
- Interest in technology and European regulations
- Experience as Regulatory Affairs Manager in a MD company is a plus
- Detailed understanding of MDD/IVDD & MPG is preferable
- Experience as Safety officer for medical devices is a plus
- Organization and planning skills
- Auditor qualification is a plus
- Ability to work across cultures
- Project management, presentation, communication, negotiation and interpersonal skills
- Enjoying working professionally in international teams is one of your strengths. Busi-
ness trips within our region are part of your job that you consider as enrichment, not as
a burden.