Medical Device Quality Professional
2 weeks ago
We are seeking a Regulatory Compliance Specialist to join our team at Aurevia Oy. The successful candidate will be responsible for ensuring compliance with regulatory requirements, managing quality management systems, and providing guidance on technical documentation.
Key qualifications include a strong background in quality management systems, regulatory compliance, and technical documentation. The ideal candidate will have 4+ years of experience in the medical device industry, with expertise in ISO 13485, ISO 14971, MDR, IVDR, and software lifecycle management processes.
The role requires excellent project management and communication skills, as well as a proactive mindset and ability to manage multiple projects simultaneously. Fluency in English (spoken and written) is essential, and Finnish proficiency is preferred.
Aurevia Oy offers a dynamic and collaborative work environment, flexible work arrangements, and a comprehensive benefits package, including salary commensurate with expertise and work experience, health insurance, and phone benefit.
- Strong expertise (4+ years) in the medical device industry
- Experience in quality & regulatory affairs (e.g. ISO 13485, ISO 14971, MDR, IVDR)
- Specific experience in software and IEC 62304 or in vitro diagnostics (IVD) products is an advantage
- Experience in US FDA regulations is an advantage
- University or higher education degree (MSc. or PhD.)
- Excellent project management and communication skills
- A proactive, service-oriented mindset
- Ability to manage multiple projects simultaneously and work independently
-
Medical Device Compliance Expert
1 week ago
Helsinki, Uusimaa, Finland Aurevia Full timeWe are looking for an experienced medical device quality and regulatory expert to join our team in a permanent, full-time position. As a member of our team, you will have the opportunity to provide high-quality services in quality and regulatory affairs, supporting both quality and regulatory needs throughout the entire lifecycle of medical devices and...
-
Medical Device Engineer
1 day ago
Helsinki, Uusimaa, Finland GlucoModicum Ltd Full timeGlucoModicum Ltd is seeking a skilled Electronics Engineer to join our team in the design and development of a novel non-invasive continuous glucose monitor. As a key contributor, you will participate in the development program and drive its launch as a CE marked medical device.The ideal candidate will have a strong background in electronics engineering and...
-
Quality and Regulatory Lead
1 week ago
Helsinki, Uusimaa, Finland Aurevia Full timeIn this role, you will be responsible for ensuring the quality and regulatory compliance of medical devices and quality management systems throughout their entire lifecycle. You will have the opportunity to collaborate with our skilled professionals, contributing to the development of high-quality services in quality and regulatory affairs.The ideal...
-
SAP Expert for Medical Device Consultancy
24 hours ago
Helsinki, Uusimaa, Finland Next Ventures Full timeAbout the RoleNext Ventures is seeking a highly skilled SAP consultant to support our medical device end client. As a key member of our team, you will be responsible for delivering SAP IBP and S4/HANA implementation projects.Key ResponsibilitiesProvide expert-level SAP consulting services for our medical device clientLead the implementation of SAP IBP and...
-
Technical Leadership in Medical Devices
7 days ago
Helsinki, Uusimaa, Finland Elekta Full timeAbout the RoleThis Senior Algorithm Engineer position will play a key part in guiding algorithm engineers and shaping our clinical software.You will lead feature and algorithm development, ensure medical device requirements are met, and collaborate closely with stakeholders to deliver accurate and efficient solutions.This position involves both hands-on...
-
Regulatory and Quality Assurance Manager
1 week ago
Helsinki, Uusimaa, Finland Aurevia Full timeThis role involves ensuring the quality and regulatory compliance of medical devices and quality management systems throughout their entire lifecycle. You will be part of our team of experts, contributing to the provision of high-quality services in quality and regulatory affairs.Key responsibilities include:Developing and implementing quality management...
-
Quality Control Specialist Medical Dermatology
2 weeks ago
Helsinki, Uusimaa, Finland Leo Pharma Inc. Full timeWe are looking for a skilled Quality Control Specialist Medical Dermatology to join our team at Leo Pharma Inc. The successful candidate will be responsible for ensuring the quality of our medical dermatology products.The key responsibilities of this position include:Developing and implementing quality control processesConducting testing and analysis to...
-
Albanian Medical Writing Specialists Sought
2 weeks ago
Helsinki, Uusimaa, Finland LILT AI Full timeLILT AI is a pioneering company in the field of language translation services, dedicated to empowering businesses to communicate effectively with their global audience.We are seeking skilled English into Albanian freelance translators to join our community of experts, who share our passion for delivering high-quality translations that make a real...
-
Senior Quality Assurance Engineer
3 weeks ago
Helsinki, Uusimaa, Finland Elekta Full timeAre you a current Elekta employee? Please click here to apply through our internal career site Find Jobs - Elekta .Want to join a team with a mission to improve and save lives? We continually look for motivated and skilled individuals who are interested in supporting our customers – healthcare professionals who use our products to help patients and their...
-
Senior Quality Assurance Engineer
3 weeks ago
Helsinki, Uusimaa, Finland Elekta AB (publ). Full timeWe don't just build technology. We build hope for everyone dealing with Cancer.As a Senior Quality Assurance Engineer, you will act as functional support representing Quality as part of product development teams/projects. With a focus on being the source of knowledge and expertise, you bring guidance and coaching/training on all aspects of Quality System...
-
Medical Advisor
5 days ago
Helsinki, Uusimaa, Finland 卡湯晩 Full timeJob title: Medical Advisor (FBM) Immunology RespiratoryLocation: FinlandJob type: Permanent, Full timeThis is a field based role; regular office visits will be requiredTravel is expected in the countries in scope and occasional travel within the Nordic and North Europe regionAbout the jobOur TeamNew opportunity as a Medical Advisor (FBM) in the specialty...
-
Albanian Medical Translators needed
2 weeks ago
Helsinki, Uusimaa, Finland LILT AI Full timeWhat we are looking forLilt is looking for English into Albanian freelance translators to join our Translator Community. We are interested in the following domains: Life Sciences, Medical, Medical devices, etc. If you have experience in any other domain or subdomain, please state it clearly on your resume.Please note that this is a remote, freelance...
-
Regulatory Affairs Specialist
1 week ago
Helsinki, Uusimaa, Finland Aurevia Full timeWe are seeking an experienced medical device quality and regulatory expert to join our team in a permanent, full-time position. This role offers diverse and impactful assignments, ranging from large-scale projects to smaller tasks, such as bringing a new medical device to selected markets, establishing a quality management system, creating a regulatory plan...
-
Regulatory Affairs Expert
3 weeks ago
Helsinki, Uusimaa, Finland Aurevia Full timeWe are looking for an experienced medical device quality and regulatory expert to join Aurevia in a permanent, full-time position. Join our team of dedicated medical device professionals, providing high-quality services to economic operators across the industry. Our services address both quality and regulatory needs throughout the entire lifecycle of medical...
-
Regulatory Affairs Expert
4 weeks ago
Helsinki, Uusimaa, Finland Aurevia Oy Full timeAre you our next Quality Maker?We are looking for an experienced medical device quality and regulatory expert to join Aurevia in a permanent, full-time position. Join our team of dedicated medical device professionals, providing high-quality services to economic operators across the industry. Our services address both quality and regulatory needs throughout...
-
Mobile Device Tester
2 weeks ago
Helsinki, Uusimaa, Finland Marquistech Pvt. Ltd Full timeJob DescriptionWe are seeking a skilled Mobile Device Tester to join our team at Marquistech Pvt. Ltd. As a key member of our testing department, you will be responsible for ensuring the quality and reliability of our mobile devices.Your primary duties will include:Conducting thorough tests on various mobile devices to identify any defects or...
-
Scientific Medical Liaison
5 days ago
Helsinki, Uusimaa, Finland 卡湯晩 Full timeAt 卡湯晩, we are seeking a Scientific Medical Liaison to implement the medical and scientific strategy for the Immunology Respiratory therapeutic area. As a key member of our team, you will develop trusted partnerships with healthcare professionals and institutions in Finland. Your role will involve engaging proactively and reactively with HCPs and...
-
Helsinki, Uusimaa, Finland GE HealthCare Voluson Ultrasound Full timeJob Description SummaryAs a Lead Supplier Quality and Development Engineer you will be responsible for driving exceptional purchased part/product quality for the patient safety, customer value beyond expectations, and optimized cost of quality for GE healthcare. You will have an opportunity to utilize your strong injection molding, precision...
-
Data Quality Analyst
2 weeks ago
Helsinki, Uusimaa, Finland Huawei Full timeHuawei Consumer Business Group is the leader in the all-scenario AI life. It covers smartphones, PC and tablets, wearables, mobile broadband devices, family devices and device cloud services. Huawei Consumer Business Group is dedicated to delivering the latest technologies to consumers and sharing the happiness of technological advances with more people...
-
Data Quality Analyst
2 weeks ago
Helsinki, Uusimaa, Finland Huawei Finland R&D Full timeHuawei Consumer Business Group is the leader in the all-scenario AI life. It covers smartphones, PC and tablets, wearables, mobile broadband devices, family devices and device cloud services. Huawei Consumer Business Group is dedicated to delivering the latest technologies to consumers and sharing the happiness of technological advances with more people...