Carl Zeiss Meditec AG
Regulatory Affairs Manager, Fokus Surgical Posterior Segment(m/w/x)
Vollzeitnur vor OrtBerufserfahren
Oberkochen
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CACarl Zeiss Vision International GmbH
Senior Expert Regulatory Affairs(m/w/x)
Aalen
VollzeitVor OrtManagement
Nejo KI-Zusammenfassung
Global regulatory pathways for ophthalmic lenses and medical device software. Experience with medical device software (IEC 62304) or pharma regulations, plus EU notified bodies, required. Work in multicultural environment.
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
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
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- ISO 13485
- MDSAP
- PRRC
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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Clinical Affairs Manager Microsurgery (MCS)(m/w/x)
Vollzeitnur vor OrtBerufserfahrenOberkochen
CACarl Zeiss Vision International GmbH
Senior Expert Regulatory Affairs(m/w/x)
Aalen
VollzeitVor OrtManagement
Nejo KI-Zusammenfassung
Global regulatory pathways for ophthalmic lenses and medical device software. Experience with medical device software (IEC 62304) or pharma regulations, plus EU notified bodies, required. Work in multicultural environment.
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
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
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- ISO 13485
- MDSAP
- PRRC
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.
Über das Unternehmen
Carl Zeiss Vision International GmbH
Branche
Manufacturing
Beschreibung
The company is a leading manufacturer of ophthalmic lenses, helping people achieve clearer vision sustainably.
Noch nicht perfekt?
- Carl Zeiss Meditec AG
Regulatory Affairs Manager, Fokus Surgical Posterior Segment(m/w/x)
Vollzeitnur vor OrtBerufserfahrenOberkochen - Carl Zeiss Vision International GmbH
Head of Quality and Regulatory(m/w/x)
Vollzeitnur vor OrtManagementAalen - Carl Zeiss Meditec AG
Regulatory Affairs Manager(m/w/x)
VollzeitBefristeter Vertragnur vor OrtJuniorOberkochen - Carl Zeiss Meditec AG
Manager Labeling & Regulatory Projects(m/w/x)
Vollzeitnur vor OrtBerufserfahrenOberkochen - Carl Zeiss Meditec AG
Clinical Affairs Manager Microsurgery (MCS)(m/w/x)
Vollzeitnur vor OrtBerufserfahrenOberkochen