Regulatory Affairs Expert

Aurevia Oy is a leading expert organization in quality and regulatory affairs within the Nordic region. We are seeking an experienced medical device quality and regulatory expert to join our team.The successful candidate will be responsible for:Building, maintaining, and developing the Quality Management SystemPlanning, creating, updating, and providing...

As a mid-senior level professional, you will have the opportunity to take on leadership roles and contribute to the growth of our organization. With Aurevia, you can enhance your skills and experience in quality and regulatory affairs, advancing your career in the medical device industry.Seniority LevelMid-Senior level

We offer a front-row view to the medtech industry within Nordic's leading expert organization in quality and regulatory affairs. Our team members have extensive experience and expertise ensuring a strong local support network and a platform for discussions in an ever-changing environment.Required Skills and QualificationsStrong expertise (4+ years) in the...

Aurevia offers diverse and impactful assignments in quality and regulatory affairs, ranging from large-scale projects to smaller tasks such as bringing a new medical device to selected markets. Our clients benefit from our comprehensive knowledge and expertise in quality management systems and regulatory compliance.BenefitsYou will become part of a...

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RequirementsSolid understanding and proven working experience with ISO 13485, EU MDR, and 21 CFR §820Internal auditing certification or proven experience in internal auditingHands-on experience in CAPA processKnowledge of IEC 62304 and ISO/IEC 27001 is seen as an advantageStrong written and verbal communication skillsExcellent collaboration...

Our TeamWe're a dynamic and motivated team at Topcon Healthcare Solutions Oy, and we welcome you to join us! As a Quality Manager, you'll have an impact on ensuring the delivery of high-quality software products focused on customer needs. Your responsibilities will include acting as an Internal Auditor - ISO 13485:2016, guiding cross-functional teams through...

Role OverviewWe are seeking a highly skilled and experienced legal professional to join our Corporate Legal Affairs team at Wärtsilä Corporation. As a Group Legal Counsel, you will play a critical role in supporting the ICT sourcing team and the larger Indirect Procurement organization in their contracting activities.Your focus will be on providing expert...

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