Regulatory Affairs Expert for Medical Devices
hace 1 día
Job Overview
Ablecloset is currently seeking a highly skilled Regulatory Affairs Expert to join its Corporate Regulatory Affairs Team in Esplugues del Llobregat (Barcelona). As a Pre-Market Regulatory Affairs Engineer, you will play a crucial role in ensuring that our new product development and design changes meet regulatory requirements.
About the Role
In this position, you will work closely with Research and Development, Quality Assurance, and other business departments to ensure compliance with UK, European, USA, and International country-specific legislations. Your primary responsibilities will include preparing dossiers and technical documentation for product submissions worldwide, managing submissions with regulatory agencies, and providing operational regulatory input and guidance to cross-functional teams.
Your Skills & Experience
- Minimum 5 years of experience in Regulatory Affairs (Pre-Market) within a Medical Device company with active medical devices (energy devices)
- Specific knowledge of active devices and associated standards (e.g., IEC 60601/IEC 62304)
- Experience with the Medical Device Regulation and other relevant regulations (e.g., UE, EEUU, Canada)
- Excellent attention to detail when reviewing and preparing documentation
- Organized, target-orientated, flexible, good time management skills
- Strong written and oral communication skills in English
What We Offer
- A competitive salary range: €60000 - €80000 per year
- A dynamic and supportive work environment
- Ongoing training and professional development opportunities
- A chance to work on challenging projects and contribute to the growth of Ablecloset
How to Apply
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