Carl Zeiss Meditec AG
Regulatory Affairs Manager, Fokus Surgical Posterior Segment(m/w/x)
Vollzeit
Berufserfahren
Keine Angabe
Oberkochen
CA
Carl Zeiss Vision International GmbH1 Monat
Senior Expert Regulatory Affairs(m/w/x)
Management
Vollzeit
Keine Angabe
Aalen
Nejo KI-Zusammenfassung
In this role, you will navigate the complexities of regulatory affairs, ensuring product compliance from authorization to discontinuation while leading efforts to secure necessary approvals across various markets.
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Anforderungen
- •BS/MSc in Life Sciences, Engineering, Optics, Regulatory Affairs, or related experience
- •Strong experience in regulatory affairs and quality management, preferably in medical devices, ideally with experience in standalone or embedded medical device software and IEC 62304, or in pharma
- •Understanding and proven track record working with notified bodies and regulatory authorities in Europe
- •Strong knowledge of regulatory requirements and processes in relevant markets combined with advanced project management skills, time and budget management proficiency in a multicultural environment
- •Certifications in ISO 13485, MDSAP, PRRC, or any other certification related to Life Science/Regulatory affairs is a plus
- •Experience with FDA requirements and successful submissions (e.g., 510(k) and FDA audits) in addition to knowledge regarding digital processes in RA (incl. submissions, digitalization and intelligence)
- •Strong analytical and problem-solving skills as well as a solid customer and result oriented focus
- •Excellent communication and negotiation skills expressed with fluency in English and German
Bachelor-Abschluss
Berufserfahrung
ca. 4 – 6 Jahre
Deine Aufgaben
- •Develop global regulatory pathways for product authorizations
- •Prepare and submit regulatory documents to authorities
- •Ensure product compliance throughout their lifecycle
- •Maintain regulatory compliance for product labeling
- •Support clinical trials with regulatory guidance
- •Lead efforts to obtain approvals and licenses in various markets
- •Integrate regulatory elements into business processes
- •Maintain and update regulatory documentation for Quality Management Systems
- •Assess marketing claims for regulatory compliance
Tools & Technologien
ISO 13485MDSAPPRRC
Sprachen
Englisch – verhandlungssicher
Deutsch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Carl Zeiss Vision International GmbH 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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