Quality and Regulatory Lead

1 week ago


Helsinki, Uusimaa, Finland Aurevia Full time

In 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 candidate will have:

  • 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
  • Fluent proficiency in English (spoken and written), additionally Finnish proficiency is preferred

You will also have the opportunity to:

  • Participate in the development of our services and contribute to the growth of our company
  • Collaborate with our international teams in Finland, Sweden, Poland, and Germany
  • Support our customers in meeting their quality and regulatory requirements


  • Helsinki, Uusimaa, Finland Aurevia Full time

    This 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...


  • Helsinki, Uusimaa, Finland Elekta AB (publ). Full time

    We're seeking a highly skilled Quality Systems Engineer and Regulatory Expert to join our team at Elekta AB (publ.). This role is part of our driven global team, where we aim to attract and invite the best competences to deliver software and hardware solutions in a secure and sustainable way.In this exciting and diverse role, you will represent Quality on...


  • Helsinki, Uusimaa, Finland Paulig Group Full time

    At Paulig, we believe every meal counts. As an international player in the food and beverage industry and as a house of iconic brands, we can make an impact that counts – and careers that matter.Are you interested in assuring safe and high-quality retail and out-of-home products to and from all over the world and working with raw material sourcing projects...


  • Helsinki, Uusimaa, Finland Aurevia Oy Full time

    Are 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...


  • Helsinki, Uusimaa, Finland Aurevia Full time

    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 the entire lifecycle of medical...


  • Helsinki, Uusimaa, Finland Aurevia Full time

    We 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...


  • Helsinki, Uusimaa, Finland GE HealthCare Voluson Ultrasound Full time

    Job 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...


  • Helsinki, Uusimaa, Finland Visma Numeron Oy Full time

    As a Quality Engineering Lead at Visma Numeron Oy, you'll be responsible for leading our QA Team in designing, developing, and maintaining test automation frameworks and systems. Your primary goal will be to ensure the quality and reliability of our software products.Our ideal candidate has 8+ years of experience in architecting, developing, deploying, and...


  • Helsinki, Uusimaa, Finland GE HealthCare Voluson Ultrasound Full time

    GE HealthCare is a leading global medical technology and digital solutions innovator. We are harnessing the power of technology to make healthcare more precise, personalized, and accessible for everyone.We develop life-changing medical solutions in monitoring, diagnostic cardiology, acute care, anesthesia, and respiratory care, and maternal and infant care....


  • Helsinki, Uusimaa, Finland Syneos Health, Inc. Full time

    Role and ResponsibilitiesThe Regulatory Compliance Expert will be responsible for ensuring that all site-level activities are conducted in accordance with regulatory requirements. This includes conducting site visits to assess compliance, verifying informed consent processes, and managing site-level activities to ensure project objectives are met.The ideal...

  • Electrical Lead

    3 weeks ago


    Helsinki, Uusimaa, Finland Winthrop Engineering and Contracting Limited Full time

    Winthrop is a dedicated Data Centre Construction company providing turnkey solutions to our clients, headquartered in Dublin and delivering throughout Europe. As an engineering-focused organization, Winthrop has grown to become one of the leading and most trusted companies in our sector. We are currently constructing multiple Turnkey Data Centre Projects...

  • MEP Lead

    2 weeks ago


    Helsinki, Uusimaa, Finland Winthrop Engineering and Contracting Limited Full time

    Winthrop is a dedicated Data Centre Construction company providing turnkey solutions to our clients, headquartered in Dublin and delivering throughout Europe. As an engineering-focused organization, Winthrop has grown to become one of the leading and most trusted companies in our sector. We are currently constructing multiple Turnkey Data Centre Projects in...

  • Mechanical Lead

    3 weeks ago


    Helsinki, Uusimaa, Finland Winthrop Engineering and Contracting Limited Full time

    Winthrop is a dedicated Data Centre Construction company providing turnkey solutions to our clients, headquartered in Dublin and delivering throughout Europe. As an engineering-focused organization, Winthrop has grown to become one of the leading and most trusted companies in our sector. We are currently constructing multiple Turnkey Data Centre Projects...


  • Helsinki, Uusimaa, Finland Aurevia Oy Full time

    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...


  • Helsinki, Uusimaa, Finland Leo Pharma Inc. Full time

    Required Skills and QualificationsA Master's degree in Pharmacy and registration in Finland are essential qualifications for this role.At least 5 years of relevant experience in the regulated pharmaceutical industry, specifically including Quality Assurance/Quality Control and/or Regulatory Affairs, is required.Fluent English language proficiency (B2 level...


  • Helsinki, Uusimaa, Finland Blackfield Associates Full time

    Quality Commissioning Lead – Mission Critical Systems (Data Centres)Join a global leader in quality & commissioning for high-tech infrastructure. As a Quality Commissioning Lead (QCx), you'll ensure seamless project execution from mechanical completion to commissioning and handover, driving operational readiness for mission-critical systems.Your RoleAct as...


  • Helsinki, Uusimaa, Finland Elekta AB (publ). Full time

    We 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...


  • Helsinki, Uusimaa, Finland Leo Pharma Inc. Full time

    At Leo Pharma Inc., we are dedicated to delivering high-quality pharmaceutical products that meet the needs of our patients. As a Pharmaceutical Quality Assurance Specialist, you will play a crucial role in ensuring the integrity of our products.The key responsibilities of this position include:Quality oversight of affiliates and local market release in the...


  • Helsinki, Uusimaa, Finland Leo Pharma Inc. Full time

    We 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...


  • Helsinki, Uusimaa, Finland Elekta Full time

    Are 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...