Specialist Technical Documentation Medical devices (m/f/d)

Riester; Ulm; Hybrid; EUR 45.000 - 75.000; Vollzeit

Zusammenfassung

Ein etabliertes Unternehmen in der Medizintechnik sucht einen engagierten Technical Documentation Specialist, der die Erstellung und Optimierung technischer Dokumentationsprozesse vorantreibt. Diese spannende Rolle beinhaltet die Verantwortung für die Erstellung und Pflege von Dokumentationen gemäß MDR-Vorgaben, die enge Zusammenarbeit mit den Teams für Forschung und Entwicklung sowie Qualitätsmanagement, um sicherzustellen, dass alle Dokumente den höchsten Standards entsprechen. In einem freundlichen und internationalen Arbeitsumfeld mit flexiblen Arbeitszeiten und zahlreichen Entwicklungsmöglichkeiten haben Sie die Chance, Ihre Fähigkeiten in einem dynamischen Team einzubringen und weiterzuentwickeln.

Leistungen

Flexible Arbeitszeiten

30 Tage Urlaub

Zugang zu Schulungen und Weiterbildungen

Teamevents

Frisches Obst und Kaffee im Büro

Qualifikationen

• Mehrjährige Erfahrung in der technischen Dokumentation im Bereich Medizinprodukte.
• Kenntnisse der regulatorischen Anforderungen, insbesondere MDR und ISO 13485.

Aufgaben

• Verantwortung für die Erstellung und Pflege technischer Dokumentation gemäß MDR.
• Zusammenarbeit mit R&D und Qualitätsmanagement zur Einhaltung von Vorschriften.

Kenntnisse

Erstellung und Pflege technischer Dokumentation

Kenntnisse der MDR und ISO 13485

Prozessoptimierung

Analytische Fähigkeiten

Kommunikationsfähigkeiten

Teamarbeit

Ausbildung

Technischer oder wissenschaftlicher Abschluss

Tools

Digitale Lösungen für Dokumentationsprozesse

Jobbeschreibung

Specialist Technical Documentation Medical devices (m/f/d)

Riester, part of the global Halma Group, is a leader in medical technology, specializing in diagnostic devices for primary and hospital care. Headquartered in Jungingen, Germany, with regional offices in the USA and Brazil, we pride ourselves on innovation, quality, and a strong global distribution network reaching over 150 countries.

About the Role

To strengthen our R&D team, we are seeking an experienced Technical Documentation Specialist (m/f/d) who is passionate about advancing the creation and optimization of technical documentation processes, while contributing hands-on to the development and refinement of critical documents.

By applying your expertise in regulatory requirements and process optimization, you will drive the creation of comprehensive and compliant technical documentation.

Responsibilities

1. Take ownership of the creation, maintenance, and optimization of Technical Documentation (TD) in compliance with MDR requirements.
2. Actively contribute to the hands-on development of documentation, ensuring accuracy, completeness, and compliance.
3. Manage and coordinate the transition of product files from MDD to MDR.
4. Support product development projects by ensuring the creation of comprehensive and compliant Product Dossiers.
5. Identify and implement improvements in the format, structure and content of existing Technical Documentation.
6. Drive the digitization of Technical Documentation processes.
7. Collaborate closely with R&D and Quality Management teams to meet regulatory requirements.
8. Train and advise colleagues on all topics related to Technical Documentation.
9. Monitor and ensure adherence to international standards and guidelines (e.g., ISO 13485, MDR).

Qualifications

1. A degree in a technical, scientific, or related field.
2. Several years of professional experience in creating and maintaining Technical Documentation in the medical device industry, including under MDR regulations.
3. Solid knowledge of regulatory requirements, particularly MDR and ISO 13485.
4. Participation in a transition project to bring technical files from MDD to MDR.
5. Proven expertise in streamlining documentation processes and implementing digital solutions.
6. Structured, solution-oriented with strong analytical skills and a team-oriented approach.
7. Excellent communication skills and experience in training colleagues.
8. Fluency in German and English, both written and spoken.

What We Offer

1. Flexible working hours with remote work options.
2. A friendly, diverse, and international work environment with flat hierarchies.
3. 30 days of annual leave.
4. Access to training and development.
5. Team events and a welcoming office stocked with fresh fruit and coffee.

Are you interested? We look forward to receiving your application, including your salary expectations and earliest possible start date.

Seniority level

Associate

Employment type

Full-time

Job function

Engineering, Quality Assurance, and Project Management

Industries

Medical Equipment Manufacturing