Regulatory Affairs Specialist

Randstad Professionals is actively looking for a Regulatory Affairs Specialist to join their pharmaceutical client in Oberdorf Baselland, Switzerland.

Responsibilities:
-Make sure that the medical devices are compliant with the product development process and with the applicable regulatory requirements (eg MDD 93/42/EEC)
-Organization and administration of technical documentation
-Update the technical documentation regarding current and new regulatory requirements and make sure that the documentation is conform with the EU and country specific requirements
-Evaluation of medical devices regarding their risk potential (based on EN ISO 14971)
-Establish and support product related information (eg IFUs, Surgical Technique guides)
-Support international releases of medical devices
-Prepare and support audits
-Support optimization of company internal procedures

Requirements:
-Scientific, medical or engineering background
-Minimum 1-3 years experience in Regulatory Affairs (MDD 93/42/EEC) of Medical Devices (focus on Class l, lla and llb)
-Experience in US Regulatory Affairs preferable

Language:
English (must)
German preferred

Personal Skills:
-Able to work under pressure
-Decisive
-Communicative competence
-Team player
-Ability to assert oneself
-Pragmatic and solution-driven working style

If this role sparked your interested, don't hesitate to send in your application!

Good to know you
Charlotte