QA/RA manager

Company DescriptionScale-up having one product on the market, in the field of regenerative medicine and orthopedicsRole DescriptionThis is a full-time, on-site role for a QA/RA Manager located in Driebergen (hybrid). The QA/RA Manager will oversee quality assurance and regulatory affairs activities, ensuring compliance with industry standards and regulations. Responsibilities include maintaining quality management systems, conducting quality audits and ensuring adherence to ISO13485 & MDR . The role involves collaborating with cross-functional teams to maintain and enhance the organization's quality standards. Additionally, The QA/RA Manager will contribute to the maintainance of the Technical Documentation as well as creation for new products.QualificationsProficiency in Quality Assurance and Regulatory AffairsExperience with ISO13485 & MDR and compliance with industry standardsProven ability to perform Quality AuditingStrong leadership and communication skills with the ability to manage cross-functional teamsPrior experience in QA/RA relevant to the industryAnalytical thinking and problem-solving capabilitiesBachelor's or Master's degree in a Life Sciences disciplineExperience in medical device industryKnowlegdeable in, a.o., risk management, biocompatibility, sterilizationProficiency in English