Job Title: (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, software, IVD
and endoscopy medical devices.

For the European Medical Systems Division we are looking for a

(Junior) Regulatory Affairs 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

equivalent 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. Business trips
within our region are part of your job that you consider as enrichment, not as a burden.

We offer you an exciting, challenging position with highly international work, an attractive
compensation package and social benefits of an international company.

If you are interested in joining our European team, please send your complete
application until 30.03.2017 (including education and qualification certificates)
preferably by e-mail to: mario_beckermann@fujifilm.eu.