Contractor Regulatory Affairs Specialist (m/w/d)
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Freelance
Job title: Contractor Regulatory Affairs Specialist (m/w/d)
Industry: MedizintechnikSkills: Regulatory Affairs
Start of project: 01.10.2022
Duration of the project : 3 Monate
Project volume: 504 Stunde(n)
Location: Schweiz
Tasks:
- Support MDR compliance execution work by creation/update of Technical Documentation of existing devices to compy with MDR requirements
- Guide conformance with applicable regulations in product development
- As required, coordinate with various Technical file cross functional teams to make sure that data is aligned across the spectrum
- Supporting team's daily operations of regulatory processes to ensure compliance with routine regulatory reporting obligations
- Support for routing and implementation of the remediated documents in PLM systems
- Support preparation of technical or design dossier documentation for submission to and review by Notified Bodies, as required
Qualifications:
- Bachelor's or Master’s Degree in engineering or life sciences (or comparable)
- Profound experience in European Medical device as regulatory affairs specialist
- Strong knowledge of ISO 13485 and ISO 9001
- Understanding of MDR requirements regarding required content of Technical Documentation (focus on ANNEX II of Regulation (EU) 2017/745)
- Strong understanding of Risk Management process, label and labeling, change management is desired
- English fluent, German is beneficial
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Kontakt
Bjarne Keller
11980
Medizintechnik
01.10.2022
3 Monate
Freelance