Senior Regulatory Affairs Consultant (with IVD Experience)

Edelway/AKKA life sciences is an European leading engineering services company.

We are currently looking for an experienced Senior Regulatory Affairs Consultant (with IVD experience) to join our teams at our global pharmaceutical client based in Basel.

Start: ASAP

Contract: (permanent or freelance contract could be discussed)

The role:
The regulatory affairs specialist contributes to the innovate and develop process by obtaining market clearance.
Prepares submission files for new product approvals (Medical Devices) including CE marking
Direct responsibility of global market clearances for multiple products.
Manages registration files including required responses to regulatory agencies.
Provides technical support and guidance to Regulatory Affairs team in charge of Global registration activities. (ASPAC, LATAM, METERA, etc.).
Provides guidance to and represents Regulatory Affairs on project teams. Creates, monitors and controls regulatory project schedules.
Contributes to the definition and implementation of regulatory procedures.
Manages communication with regulatory agencies and notified body on regulatory procedures.

Your profile:
Bachelor's degree in a scientific discipline. Life sciences or related field is preferred.
Knowledge of European and US regulations related to medical devices with a focus on In Vitro Diagnostic devices.
6 or more years' experience working with European regulations (CE marking), US FDA CDRH (510k, PMA, Pre IDE, annual reports) a plus.
Overall understanding of international regulations (Japan, China, Canada, Brazil, etc.).
Knowledge of quality systems as they relate to regulatory activities.
English a must, German a strong plus

If you want to apply, send me your CV,

(see below)