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Contractor Regulatory Affairs Specialist (m/w/d) (DE)

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Regulatory Affairs

Job title: Contractor Regulatory Affairs Specialist (m/w/d) Industry: Medizintechnik Skills: 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

Job title: Contractor Regulatory Affairs Specialist (m/w/d)
Industry: Medizintechnik
Skills: 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

map Schweiz date_range 01.10.2022 update Freelance
Direct contact

Bjarne Keller

Recruitment Consultant
mail b.keller@aristo-group.ch
phone +41 44 274 39 00


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