Regulatory Affairs Specialist

For our partner in biotechnology industry, Kelly Life Sciences is looking for:

Regulatory Affairs Specialist

(Permanent contract)

Your responsibilities:

• Verifying the conformity of IVD medical devices in accordance to the requirements of the European IVD Directive 98/79/EC and 2017/746
• Building and updating technical documentation of IVD reagents and instruments
• Coordination of the submission of registration files to the Notify Body
• International coordination to define the regulatory strategy with their subsidiaries

Your profile:

• Scientific degree in biology or pharmacy or equivalent
• Minimum 4 years of experience in regulatory affairs and knowledge in medical devices industry is an asset
• Knowledge of immuno hematology is an asset
• US/FDA regulatory knowledge is an asset (BLA; 510K)
• Good writing and communication skills
• Languages: Fluent in English, good command of German and/or French is a plus

Your contact at Kelly: Anaïs Mieszczak and Manon Mottet