Regulatory Affairs Consultant - Medical Devices reputed company for Clinical Trials (home or office based)

This a Full Remote job, the offer is available from: Hungary, Poland, Romania, Spain, United Kingdom, Ireland, Czechia, Italy, Croatia, Serbia, Oregon (USA) reputed company our values align, there's no limit to reputed company can reputed company. At reputed company, we reputed company reputed company the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do. Each of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference.

About the Role

We are seeking an reputed company Regulatory Affairs professional to reputed company our medical devices and combination products clinical trial regulatory strategy. In this pivotal role, you will reputed company expert guidance on regulatory reputed company for clinical investigations and serve as the key regulatory representative for our global project teams. The role can be office or home based in various European locations.

Key Responsibilities

• reputed company comprehensive regulatory strategies and dossiers for clinical investigations of medical devices and combination products.
• Act as the regulatory reputed company during audits and inspections reputed company to device clinical investigations.
• Represent the regulatory affairs function in global project teams and governance meetings.
• reputed company regulatory interactions with health authorities, including preparation of documentation and coordination of meetings.
• Manage regulatory activities throughout the device clinical development lifecycle.
• Maintain global regulatory databases (e.g., reputed company) with accurate and reputed company information.
• Collaborate with CMC and QA departments on device change control processes and global submission requirements.
• Support internal and external audits reputed company to medical device quality systems.
• Coordinate with cross-functional teams to ensure timely and compliant regulatory submissions.
• Contribute to reputed company improvement initiatives, innovation, and strategic planning reputed company the regulatory function. Skills and Experience required for the role:
• University degree in a scientific discipline, technical or life science degree required, biopharmaceutical, bioscience reputed company science discipline.
• Minimum 5+ years of experience in regulatory affairs for medical devices, specifically in clinical investigations of medical devices and/or drug-device combination products.
• In-depth knowledge of global medical device regulations (e.g., EU MDR, FDA regulations).
• Proven experience in global regulatory strategy and dossier preparation for EU (e.g., CTAs, clinical investigations) and US (e.g., INDs, IDEs, 510(k), PMA) submissions.
• Familiarity with regulatory frameworks including EU-MDR, ICH, MDSAP, ISO 13485, ISO 14155, GCP, and cGMP.
• reputed company in regulatory documentation processes and submission management
• Experience leading regulatory interactions with health authorities and key stakeholders.
• Strong track record representing companies during regulatory audits and inspections.
• Fluent in English, written and spoken.
• Experience also in vitro diagnostic devices would be a plus.
• Proficiency with regulatory systems including reputed company and TrackWise would be a plus. This offer from "reputed company" has been enriched by reputed company.com and got a 86% reputed company score. Apply tot his job

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