Responsibilities
Assessment of design and manufacturing changes to ensure compliance with regulatory requirements and that sufficient information is available to perform the regulatory impact assessment of the change Coordinate and contribute to worldwide assessment of changes and support the related product and production lifecycle activities Maintain regulatory documentation up to date for worldwide regulatory purposes Support the registration of changes for class II and III devices in the CE, US, Japan and other highly regulated countries Coordinate and submit deficiency responses to relevant certification bodies and country authorities Requirements
University degree in natural science, pharmacy, pharmacology, medicine or engineering At least 2 years of experience with the registration of medical devices and regulatory assessment of changes in Europe and other highly regulated countries Literate in Microsoft Office and Adobe Acrobat applications Reliable and communicative personality Ability to work in multidisciplinary teams with different backgrounds (R&D, Production, Quality, Marketing, Clinical) Attention to details, excellent organization and analytical skills, and ability to work simultaneously on multiple and sometimes urgent projects with tight timelines. Ability to adapt to program/timeline changes as needed Fluency in English is mandatory.
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Assessment of design and manufacturing changes to ensure compliance with regulatory requirements and that sufficient information is available to perform the regulatory impact assessment of the change Coordinate and contribute to worldwide assessment of changes and support the related product and production lifecycle activities Maintain regulatory documentation up to date for worldwide regulatory purposes Support the registration of changes for class II and III devices in the CE, US, Japan and other highly regulated countries Coordinate and submit deficiency responses to relevant certification bodies and country authorities Requirements
University degree in natural science, pharmacy, pharmacology, medicine or engineering At least 2 years of experience with the registration of medical devices and regulatory assessment of changes in Europe and other highly regulated countries Literate in Microsoft Office and Adobe Acrobat applications Reliable and communicative personality Ability to work in multidisciplinary teams with different backgrounds (R&D, Production, Quality, Marketing, Clinical) Attention to details, excellent organization and analytical skills, and ability to work simultaneously on multiple and sometimes urgent projects with tight timelines. Ability to adapt to program/timeline changes as needed Fluency in English is mandatory.
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Regulatory Affairs Specialist – 3-year Contract Arbeitgeber: Jobtailor
Als Global Director B2B – Business Development bei uns profitieren Sie von einer dynamischen und innovativen Arbeitsumgebung, die auf Zusammenarbeit und Kreativität setzt. Wir bieten Ihnen nicht nur attraktive Vergütungsmodelle und umfassende Weiterbildungsmöglichkeiten, sondern auch die Chance, in einem internationalen Team zu arbeiten, das Vielfalt und persönliche Entwicklung fördert. Unsere Unternehmenskultur legt großen Wert auf Flexibilität und Work-Life-Balance, sodass Sie Ihre Karriereziele in einem unterstützenden Umfeld erreichen können.
