A small to medium size company with an innovative pipeline of Medical Devices launched, many of which already internationally regulatory approved (EU, USA, Asia), currently preparing to scale up our international business, we need to internally reinforce our Management team with a:
Your mission: Lead the Quality and Regulatory activities of the company
† Maintain and monitor the QMS activities and be accountable for ISO 13485 and MDSAP certifications,
† Maintain and develop the Technical Files of existing and new devices and be accountable for the necessary regulatory approvals globally,
† Ensure all activities translate in high intrinsic quality of products manufactured by supporting the Management, R&D, Supplying and Manufacturing teams.
† Report directly to the CEO.
† Solution-oriented, you have a background in RA/QA of a minimum 5 years,
† You know how to work efficiently and autonomously, but also interface with various internal and external stakeholders,
† Robust knowledge of Class I and class II medical devices applicable laws and standards,
† Fluent in English and French.
What we offer:
† The Company is based in Switzerland and the candidate will be eligible to work remotely from Switzerland or a close country, with time-to-time travels to attend meetings, trainings &/or perform audits.
† A competitive package with possible partial activity.
Ready for the challenge ?
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