Quality & Regulatory Specialist (Medical Devices)
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I am a Quality Assurance and Regulatory professional with hands-on experience in ISO 13485-based QMS implementation, regulatory documentation, and compliance across the medical device lifecycle. I’ve contributed to successful EU MDR technical files, internal audits, CAPA investigations, and post-market surveillance activities, ensuring alignment with ISO 14971 and 21 CFR 820. My background combines strong documentation accuracy with problem-solving and analytical skills, enabling me to improve audit readiness and process efficiency.
I also bring exposure to MDSAP and global regulatory frameworks, along with a deep understanding of device classification and risk management. I am now seeking an international opportunity where I can leverage my expertise, grow in a multicultural environment, and contribute to global quality and regulatory excellence. I’m open to relocation and sponsorship opportunities across Europe or other regulated markets.
I am a Quality Assurance and Regulatory professional with hands-on experience in ISO 13485-based QMS implementation, regulatory documentation, and compliance across the medical device lifecycle. I’ve contributed to successful EU MDR technical files, internal audits, CAPA investigations, and post-market surveillance activities, ensuring alignment with ISO 14971 and 21 CFR 820. My background combines strong documentation accuracy with problem-solving and analytical skills, enabling me to improve audit readiness and process efficiency.
I also bring exposure to MDSAP and global regulatory frameworks, along with a deep understanding of device classification and risk management. I am now seeking an international opportunity where I can leverage my expertise, grow in a multicultural environment, and contribute to global quality and regulatory excellence. I’m open to relocation and sponsorship opportunities across Europe or other regulated markets.
Master's in Technology (Medical Devices)
