20 beste Stellen als process science in hamburg, hh – aktuell auf Personalsuche

Product Reviewer - Technische Dokumentation IVD (f/m/d)
TÜV SÜD —Hamburg
- Teilzeit
- Microsoft Office
5 Tage
EVP, Global Head of Quality
Evotec —Hamburg
- Führungserfahrung
Research Associate for the Project “Seismic Interferometry of Rotations: Wavefields and Sources” in the research unit RING: Rotations in Physics, Geophysics, and Geodesy
Universität Hamburg —Hamburg
- Doktorat
- Forschungserfahrung
- Master
- Flexible Arbeitszeiten
Research Associate for the ERC Project "KEBAB"
Deutsches Elektronen-Synchrotron DESY —Hamburg
- Teilzeit
- Doktorat
- Schreibfähigkeiten
- Flexible Arbeitszeiten
Data Engineer Wind Energy (m/f/d)
Nordex SE —Hamburg
- Teilzeit
- Informatik
- Softwareentwicklung
- Flexible Arbeitszeiten
Principal – SAP BTP & Agentic AI (all genders) - BCG Platinion
Boston Consulting Group —Hamburg
- Informatik
- Mit Reiseanteil
- Erfahrung in der IT
Scientist – LC/MS (all genders)
BioAgilytix —Hamburg
- Microsoft Word
- Microsoft Excel
- Doktorat
Direkt bewerben
1 Tag
Market Research Lead (all genders)
Evotec —Hamburg
- Vollzeit
- Master
- Bachelor
- Wirtschaft
- Flexible Arbeitszeiten
CFD Software Engineer
Siemens —Hamburg
- Vollzeit
- Hybrides Arbeiten
- Doktorat
- CAD
- Master
2 Tage
Sales Representative – Study Advisor (Spanish-speaking Markets) (m/f/d)
CPE Europe GmbH —Hamburg
- Vertrieb
- Englisch
- Microsoft Office
- Kostenloser Parkplatz
- Kostenlose Verpflegung
Direkt bewerben
Solution Architect Microsoft Dynamics 365 FSCM (all genders)
Arineo GmbH —Hamburg
- Ab 75.000 € pro Jahr
- Teilzeit
- Informatik
- Mit Reiseanteil
- Künstliche Intelligenz
- Reisekostenerstattung
- Employee Assistance Program
IT-Support Specialist (m/w/d)
John T. Essberger GmbH & Co. KG —Hamburg
- Vollzeit
- Azure
- Informatik
- Reisekostenerstattung
- Flexible Arbeitszeiten
Recruiter / HR Business Partner for Recruiting & Employer Branding (m/f/d)
Helm AG —Hamburg
- Personalwesen
- Recruiting
- Künstliche Intelligenz
Head of Bioinformatics (m/f/d)
Indivumed GmbH —Hamburg
- Doktorat
- Datenbanken
- Machine Learning
- Flexible Arbeitszeiten
Direkt bewerben
Planned Maintenance System (PMS) Superintendent (m/f/d)
Peter Döhle Schiffahrts-KG —Hamburg
- Vollzeit
- Wartung
- Englisch
- Microsoft Office
Direkt bewerben
Associate Unity Developer
Bigpoint GmbH —Hamburg
- Vollzeit
- Hybrides Arbeiten
- Informatik
- Systemdesign
- Mitgliedschaft im Fitnessstudio
- Flexible Arbeitszeiten
8 Tage
Analytics Engineer (f/m/d)
justDice —Hamburg
- Vollzeit
- SQL
- AWS
- Bachelor
- Employee Assistance Program
- Flexible Arbeitszeiten
Direkt bewerben
2 Tage
Capacity Development Project Manager
Kuehne Climate Center gGmbH —Hamburg
- Vollzeit
- Reden in der Öffentlichkeit
- Englisch
- Führungserfahrung
Direkt bewerben
(Senior) Clinical Trial Manager (m/f/d)
Helm AG —Hamburg
- ERP-Systeme
- Forschungserfahrung
- Microsoft Office
Assistant Manager m/w/d - Monckebergstrasse, Abercrombie & Fitch
AFH Germany GmbH —Hamburg
- 41.500 € pro Jahr
- Vollzeit
- Vertrieb
- Personalführung
- Bachelor
- Aufstiegsmöglichkeiten

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process science jobs near hamburg, hh

Product Reviewer - Technische Dokumentation IVD (f/m/d)

TÜV SÜD -
Hamburg

Jetzt bewerben

Details zur Stelle

Teilzeit | Vollzeit
vor 5 Tagen

Qualifikationen

Qualitätsmanagement
Microsoft Office
Produktentwicklung

Vollständige Stellenbeschreibung

Product Reviewer - Technische Dokumentation IVD (f/m/d)

At TÜV SÜD Group we are passionate about technology. Innovations impact our daily lives in countless ways, and we are dedicated to being a part of that progress. We test, we audit, we inspect, we advise. We never stop challenging ourselves for the safety of society and its people. We breathe technology, we strive for professional excellence, and we leave a mark. We take the future into our hands. We are TÜV SÜD Group.

Tasks:

Perform Technical Documentation Assessments (TDA) in accordance with IVDR requirements
Assess compliance of IVD devices against applicable IVDR provisions (e.g. Annex I, Annex IX, Annex X/XI)
Review and evaluate:
- Performance evaluation (scientific validity, analytical and clinical performance)
- Benefit-risk assessment and risk management documentation
- Post-Market Surveillance (PMS / PSUR) documentation
- Instructions for Use (IFU) and Summary of Safety and Performance (SSP)
Assess specific regulatory requirements for Companion Diagnostics, including interaction with medicinal product evaluation processes
Identify deficiencies and participate in iterative review cycles with manufacturers
Prepare structured assessment reports in line with notified body processes

Qualification :

The role requirements are based on IVDR expectations for notified body personnel (e.g. Annex VII competence criteria):

University degree in:
- Life sciences, medicine, biology, biochemistry, or a comparable discipline
Several years of professional experience in one or more of the following areas:
- In vitro diagnostics (IVD)
- Regulatory affairs / compliance
- Clinical/performance evaluation
- Quality management or product development
Solid understanding of IVDR (EU 2017/746) and relevant guidance documents
Experience in reviewing or preparing technical documentation is highly desirable
Expertise in Companion Diagnostics, oncology, or biomarker-based testing is a strong advantage

Additionally:

Fluent in English (written and spoken)
Structured and independent working style

At TÜV SÜD Group, we have employees from more than 100 different countries collaborating together. People of different backgrounds, skills, and pursuing different life goals. Our strength comes from these countless and varied perspectives.

We are committed to be an inclusive and diverse workplace by welcoming people of all backgrounds. We want Diversity & Inclusion (D&I) to be a foundation of our company and create an environment where all our employees can trust they will be treated with respect, regardless of gender, nationality, ethnic background, faith, beliefs, disabilities, age, sexual orientation, or identity. As such, our employees are expected to behave at all times in a manner consistent with TÜV SÜD Group Code of Ethics and Company values.

We firmly believe embedding D&I in the heart of what we do will inherently contribute to the success of TÜV SÜD Group. Click here to find out more about Diversity at TÜV SÜD Group.

Work Area: Medical Devices & Healthcare

Country/Region: Germany, Poland, Portugal, Spain, Switzerland, United Kingdom, United States

Job Location: Hamburg, Lisbon, London, Madrid, München, Newcastle, San Diego, Warsaw, Zürich

Working Model: Hybrid

Employment Type: Full time or part time / regular

Company: TÜV SÜD Produkt Service GmbH

Org Unit Code: PS-MHS-PA

Requisition ID: 5685

Duration in months (if limited contract):

Jetzt bewerben

Erweiterte Suche

process science Jobs in hamburg, hh

Product Reviewer - Technische Dokumentation IVD (f/m/d)

EVP, Global Head of Quality

Research Associate for the Project “Seismic Interferometry of Rotations: Wavefields and Sources” in the research unit RING: Rotations in Physics, Geophysics, and Geodesy

Research Associate for the ERC Project "KEBAB"

Data Engineer Wind Energy (m/f/d)

Principal – SAP BTP & Agentic AI (all genders) - BCG Platinion

Scientist – LC/MS (all genders)

Market Research Lead (all genders)

CFD Software Engineer

Sales Representative – Study Advisor (Spanish-speaking Markets) (m/f/d)

Solution Architect Microsoft Dynamics 365 FSCM (all genders)

IT-Support Specialist (m/w/d)

Recruiter / HR Business Partner for Recruiting & Employer Branding (m/f/d)

Head of Bioinformatics (m/f/d)

Planned Maintenance System (PMS) Superintendent (m/f/d)

Associate Unity Developer

Analytics Engineer (f/m/d)

Capacity Development Project Manager

(Senior) Clinical Trial Manager (m/f/d)

Assistant Manager m/w/d - Monckebergstrasse, Abercrombie & Fitch

Ich möchte aktuelle Job-E-Mails für Stellen als process science in hamburg, hh erhalten

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