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Regulatory Affairs Specialist

Il y a 5 mois

Paris e, France VIQI Temps plein

**Your responsibilities**
- Maintaining the Technical Documentation for Medical Devices with support of other functions
- Becoming familiar with regulations and standards applicable to specific areas of responsibility, which may include notified body exposure
- Support product registrations including document management
- Support the Medical Device team in approval and document reviews
- Becoming familiar with Quality System requirements for Medical Devices

**Your profile**
- Master degree or equivalent in Regulatory Affairs, Natural Sciences or Engineering and professional experience in the area of Medical Devices Regulatory Affairs or Quality Management for Medical Devices
- EU Medical Device Regulation 2017/745, MDD 93/42 and familiarity with harmonized standards such as EN ISO 13485, EN ISO 14971 or MDCG guidelines
- Ideally experienced with medical devices for the infection prevention business within an internationally operating company
- Demonstrated success in managing processes and projects self-reliantly and managing challenges as the accountable project-owner
- Ability to effectively communicate and collaborate with internal and external stakeholders on an international and virtual base combined with an analytical and solution oriented working manner
- Fluency in French, English and excellent knowledge of MS Office
- Good written and verbal communication skills
- Ability to be flexible and acceptance to travel

Remuneration : 60k - 70k

**based in Lezennes / France or Monheim am Rhein / Germany