Regulatory Affairs Specialist with Medical Device Expertise
4 settimane fa
Air Liquide Medical Systems, a leading medical devices manufacturer, is part of the global Air Liquide Group. The company develops and markets innovative products for respiratory medicine, addressing chronic conditions and ventilatory support needs.
As a Junior Regulatory Affairs Specialist, you will report directly to the QHSE/RA Manager. Your primary responsibility will be ensuring compliance of cutting-edge medical devices, making them available in the global market through dedicated registration processes.
Key Responsibilities:
* Conduct feasibility studies for the registration of new medical devices
* Collaborate with regulatory affairs, marketing, and sales teams across the organization
* Support customers with regulatory requests, adhering to required timelines
* Manage the registration of medical devices marketed in Italy and globally
* Obtain Certificates of Free Sale and follow legalization procedures for non-EU exports
* Review promotional and non-promotional material related to medical devices
* Assist the QHSE manager in quality-related activities and audits
The ideal candidate will possess a degree in Engineering (Mechanical, Biomedical, Management) and have prior experience in the role of 6 months to 1 year. Excellent English language skills are also essential. Our team at Air Liquide values diversity and inclusivity, offering opportunities for employees to express their talent and foster innovation in a dynamic environment.
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