Jobbörse

Quality Management & Regulatory Affairs Manager – Medical Devices (m/f/d)

Veröffentlicht am 26. Okt. 2026

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Neubourg GmbH & Co KG

Wolfratshausen

EnglischFließend Deutsch (C1+)

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Gehalt (Schätzung)

Grobe Schätzung: 44.000 €–58.000 €/Jahr

Über diese Stelle

As **Quality Management & Regulatory Affairs Manager (m/f/d)**, you ensure that our medical device portfolio meets the highest quality and regulatory standards. You are responsible for key QM processes for the companies of Avia Pharma Germany, keep us audit-ready at all times in line with ISO 13485 and MDR, and report directly to the Director of Scientific Affairs DACH. Your place of work is Wolfratshausen near Munich, full-time with the option to work remotely.

*Your Responsibilities**
Operational management of change control, complaint handling and CAPA for the companies of Avia Pharma Germany
Preparation and execution of internal audits and ensuring continuous audit readiness in line with ISO 13485 and MDR
Maintenance and further development of the quality management system, including support for the migration to an eQMS
Qualified regulatory support for our medical device portfolio
Contribution to the maintenance and updating of technical documentation
Support with ongoing vigilance activities
*Your Profile**
University degree in a relevant scientific, technical, medical or pharmaceutical discipline
At least one year of professional experience in regulatory affairs for medical devices

At least one year of professional experience in quality management for medical devices, including experience in CAPA, change and complaint management

Sound working knowledge of ISO 13485 and MDR

Desirable: audit experience (internal/external), ideally with an auditor qualification, as well as experience with eQMS systems and RA databases

An advantage: background in dermatology, medicinal products, cosmetics or food supplements

Strong quality mindset, great attention to detail and an independent, structured way of working

Reliability and assertiveness toward internal and external interfaces, as well as the willingness to take on broader regulatory responsibility over time

Business-fluent German and English, both written and spoken

We offer you a responsible role in a dynamic working environment with challenging tasks and plenty of room for your own initiative, including the freedom to explore new paths. Short decision-making processes and flat hierarchies help us implement exciting ideas quickly and without red tape.

On top of that, you can look forward to:

First-name culture: We treat each other as equals – from apprentices to management
Flexibility: Flexible working hours and a hybrid working model
Fit & Active: eGym Wellpass membership and (e-)bike leasing
Time off: 30 days of vacation per year
Securing your future: Company pension scheme included
Team spirit: Regular team events
Little things that matter: Birthday gift, subsidy for computer glasses, plus fruit & drinks

Would you like to help shape our success story? Then we look forward to receiving your meaningful application, including your salary expectations.

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Eckdaten der Stelle

Arbeitgeber: Neubourg GmbH & Co KG
Position: Quality Management & Regulatory Affairs Manager – Medical Devices (m/f/d)
Stadt: Wolfratshausen
Arbeitsmodell: nicht angegeben
Sprache: Englisch
Erfahrungsstufe: nicht angegeben
Veröffentlicht: 26. Okt. 2026
Quelle: Bundesagentur für Arbeit

Quality Management & Regulatory Affairs Manager – Medical Devices (m/f/d)

Job Fit

Über diese Stelle

On top of that, you can look forward to:

Eckdaten der Stelle

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