Regulatory Affairs Notified Body Consultant (French Speaker)

Edelway is a Swiss pharma consulting company.

Our large Medical Devices client based in Yverdon les Bains is actively looking for a Regulatory Affairs/Notified Body Consultant (English & French speaker) to join them on an initial 2 months contract.

Start: July 2016

The purpose of the role is to support the notified body process to achieve the ISO 13485 certification.

The role:

-Conduct a conformity assessment under the relevant EU Directives
-Review of relevant documentation provided by the manufacturer in support of the safety and performance claims for the device
-Support audit of quality system
-Provide regulatory review/approval of labelling and act as liaison with Notified Body in support of product approvals

Your profile:

-Master or PhD in related field
-French and English speaker
-Strong experience in Regulatory Affairs/Quality Assurance in Europe
-Excellent written and verbal communication skills
-Experience working on cross-functional project teams
-Expert knowledge of European regulatory requirements for Class II or III devices
-Notified body/BSI knowledge
-Understanding of other global regulations
-Ideally knowledge of ISO13485

If this sound like your next challenge, please send me your CV (see below) or call me and I will call you shortly to discuss it in more details.

Keywords: CE, BSI, notified body, regulatory affairs, Quality Assurance, QA, medical devices, Suisse romande, ISO