Senior RAQA Specialist mfd Post Market Surveillance

As a Senior RAQA Specialist, you will oversee Post Market Surveillance (PMS) processes across our distribution sites in Germany, Switzerland, and Austria (GSA), ensuring compliance with MDR 2017 / 745 and local regulatory requirements such as the Swiss MedDO. You will be responsible for managing customer complaints, field safety corrective actions, and regulatory interactions. Collaborating with global manufacturing sites and cross-functional teams, you will drive continuous improvement initiatives within a dynamic and innovative environment.

What will you do

1. Ensure PMS processes comply with MDR 2017 / 745, ISO 13485, and local regulations including Swiss MedDO.
2. Manage customer complaints, field safety corrective actions, and regulatory reporting within the GSA region.
3. Respond to requests from local competent authorities and liaise with manufacturing sites worldwide.
4. Support internal and external audits related to PMS and regulatory compliance.
5. Drive process enhancements to optimize PMS activities.
6. Deliver impactful training and expert guidance to internal teams.
7. Ensure documentation and reporting of PMS activities for continuous improvement.

What will you need

Required

1. Bachelor's degree in Engineering, Science, or a related field. Master's is a plus.
2. 2 years of Regulatory Affairs & Quality Assurance (RAQA) experience, preferably specializing in Post-Market Surveillance; Complaint Handling and FSCA.
3. 2 years of experience in a medical device, pharmaceutical, or other highly regulated industry.
4. Proficiency in English and German with strong communication and collaboration skills.

Preferred

1. Knowledge of ISO 13485, MDR, and post-market surveillance requirements.
2. Hands-on experience in complaint handling.
3. Experience with digital tools for complaint handling and PMS reporting.

Diversity is important to us. We welcome applications from people regardless of their ethnic, national, or social origin, gender, disability, age, or sexual identity.

Additional information

Thanks to our flexible working hours model, you will have the opportunity to work partially from the home office. However, a regular presence of at least 1 day a week on-site at our location in Duisburg should always be given to build sustainable relationships and maintain personal contact with colleagues as well as the departments.

Please note that the internal job title may differ from the ad title.

Travel Percentage: 10

Required Experience: Senior IC

Key Skills:

Microsoft Access, SQL, Analysis Skills, Microsoft PowerPoint, Securities Law, Data Mining, Investment Banking, Market Research, Microsoft Excel, Visual Basic, Bloomberg, Data Analysis Skills