Senior RAQA Specialist mfd Post Market Surveillance
Senior RAQA Specialist mfd Post Market Surveillance
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Job Description
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 crossfunctional teams you will drive continuous improvement initiatives within a dynamic and innovative environment.
What will you do
Ensure PMS processes comply with MDR 2017/745 ISO 13485 and local regulations including Swiss MedDO.
Manage customer complaints field safety corrective actions and regulatory reporting within the GSA region.
Respond to requests from local competent authorities and liaise with manufacturing sites worldwide.
Support internal and external audits related to PMS and regulatory compliance.
Drive process enhancements to optimize PMS activities.
Deliver impactful training and expert guidance to internal teams.
Ensure documentation and reporting of PMS activities for continuous improvement.
What will you need
Required
Bachelors degree in Engineering Science or a related field. Masters is a plus.
2 years of Regulatory Affairs & Quality Assurance (RAQA) experience preferably specializing in PostMarket Surveillance; Complaint Handling and FSCA.
2 years of experience in a medical device pharmaceutical or other highly regulated industry.
Proficiency in English and German with strong communication and collaboration skills.
Preferred
Knowledge of ISO 13485 MDR and postmarket surveillance requirements.
Handson experience in complaint handling
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 be always given to build sustainable relationships and maintain personal contact with colleagues as well as the departments.
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Travel Percentage: 10Required Experience:
Senior IC
Employment Type
Full-Time
