IN
Intuitive9 Tage
Senior Regulatory Affairs Specialist(m/w/x)
Vollzeit
Senior
Keine Angabe
Aubonne
Nejo KI-Zusammenfassung
In this role, you will be at the forefront of regulatory affairs, leading efforts in new product development and ensuring compliance with EU regulations. Your expertise will guide cross-functional teams, support product launches, and enhance regulatory processes.
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Anforderungen
- •Minimum 8 years of experience in regulatory affairs
- •Bachelor's or master's degree in engineering, Medical Technology, or related field
- •In-depth understanding of Global medical device regulations
- •Proven experience leading EU submissions for NPD projects
- •Strong organizational, leadership, and interpersonal skills
- •Meticulous attention to detail
- •Knowledge of EU regulations and directives for product compliance
- •Proficiency in English, C1 level
- •General computer proficiency, including Microsoft Office Suite
Bachelor-Abschluss
ODER
Master-Abschluss
Berufserfahrung
8 Jahre
Deine Aufgaben
- •Lead regulatory efforts in new product development projects
- •Prepare and maintain EU Medical Device dossiers and CE Mark submissions
- •Act as the main contact for Notified Bodies regarding regulatory strategies
- •Manage preparation and submission of EU Medical Device registration dossiers
- •Collaborate on EU regulatory strategies for product introductions and changes
- •Provide regulatory advice to cross-functional teams
- •Monitor changes in global and EU medical device regulations
- •Coordinate registration strategy with Sales and Marketing stakeholders
- •Participate in process improvement initiatives for regulatory submissions
- •Assist in maintaining the Quality Management System (QMS)
- •Mentor junior regulatory team members
- •Provide regulatory support to R&D, engineering, and clinical affairs
- •Respond to regulatory inquiries from key stakeholders
- •Perform additional regulatory tasks as assigned
Tools & Technologien
Microsoft Office Suite
Sprachen
Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Intuitive erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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