Marlene S.
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Marlene S. Email & Phone Number

Head of QA and RA int., QMB und PRRC (99% REMOTE) at RAYLYTIC
Location: Leipzig, Saxony, Germany 2 work roles 4 schools
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✓ Verified August 2026 3 data sources Profile completeness 86%

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Current company
Role
Head of QA and RA int., QMB und PRRC (99% REMOTE)
Location
Leipzig, Saxony, Germany
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Marlene S. is listed as Head of QA and RA int., QMB und PRRC (99% REMOTE) at RAYLYTIC, a with 20 employees, based in Leipzig, Saxony, Germany. AeroLeads shows a matched LinkedIn profile for Marlene S..

Marlene S. previously worked as Head of QA/RA int., QMB und PRRC (99% REMOTE) at Raylytic. Marlene S. holds Dr.Rer.Nat., Pharmazie (Drug Regulatory Affairs) from Rheinische Friedrich-Wilhelms-Universität Bonn.

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Email format at RAYLYTIC

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RAYLYTIC

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About Marlene S.

Seit 2016 arbeite ich in meiner 99% REMOTE Anstellung selbstständig, eigenverantwortlich, strukturiert, zuverlässig und erfolgreich als Führungskraft QA/RA für einen Medzintechnikhersteller im Home Office. In meiner beruflichen Zukunft, möchte ich meine Expertise anderweitig zur Verfügung stellen und in unten aufgezählten, von REMOTE ausführbaren Tätigkeiten (Home Office 99%) für benannte Stellen, Behörden oder beratende Unternehmen in Festanstellung, tätig werden:1. Erstellen Klinischer Bewertungen (Medical Writer) (beratende Unternehmen)2. Erstellen von Technischer Dokumentation nach MDR (beratende Unternehmen) 3. Review von Technischer Dokumentation nach MDR (Technical File Assessor bei benannte Stelle oder beratenden Unternehmen)4. PRRC5. Reg. Unterstützung bei der Zulassung von KI-MP-Software6. Vigilanz und Marktüberwachung (Behörde oder benannte Stelle)7. REMOTE Audits (QM, ISMS (nur interne Audits)) Bisher: Mehrjährige einschlägige Berufserfahrung im Qualitätsmanagement nach ISO 13485&21 CFR 820, Auditierung (intern, extern), Erstellen Technischer Dokumentationen und Klinischer Bewertungen, EU- und internationale Zulassung von Medizinprodukten und medizinischer Software (Risikoklassen 1, 1s, 1m, 2a, 2b).

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Marlene S.'s current company

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RAYLYTIC
Raylytic
Head of QA and RA int., QMB und PRRC (99% REMOTE)
Leipzig, SN, DE
Website
Employees
20
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2 roles

Marlene S. work experience

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Head Of Qa And Ra Int., Qmb Und Prrc (99% Remote)

Leipzig, Sn, De

Head Of Qa/Ra Int., Qmb Und Prrc (99% Remote)

Current
Apr 2016 - Present
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Colleagues at RAYLYTIC

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4 education records

Marlene S. education

Allgemeine Hochschulreife, Economics

Berufliches Gymnasium Für Wirtschaft, Görlitz
FAQ

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What company does Marlene S. work for?

Marlene S. works for RAYLYTIC.

What is Marlene S.'s role at RAYLYTIC?

Marlene S. is listed as Head of QA and RA int., QMB und PRRC (99% REMOTE) at RAYLYTIC.

Where is Marlene S. based?

Marlene S. is based in Leipzig, Saxony, Germany while working with RAYLYTIC.

What companies has Marlene S. worked for?

Marlene S. has worked for Raylytic.

Who are Marlene S.'s colleagues at RAYLYTIC?

Marlene S.'s colleagues at RAYLYTIC include Anika Schmidt, Andreas Baldauf, Preston Melchert, Lara Lorenz, and Falko Löffler.

How can I contact Marlene S.?

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What schools did Marlene S. attend?

Marlene S. holds Dr.Rer.Nat., Pharmazie (Drug Regulatory Affairs) from Rheinische Friedrich-Wilhelms-Universität Bonn.

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