Medical Device Regulation Expert

19 hours ago


Stockholm, Stockholm, Sweden QBtech AB Full time
Empowering Clinical Decision-Makers

Qbtech AB is a leading global company in professional ADHD tests. Our vision is to empower clinical and financial decision-makers to improve outcomes and support patients to better understand their symptoms and treatment. We are looking for a System Quality Regulatory Manager to join our global team. This role requires experience in Medical Device Software Development and Quality Management. The successful candidate will be responsible for internal and supplier audits, document control, CAPA, Change Control, Complaints, and Non-Conformances. They will also perform training in quality and regulatory matters.

Key Areas of Responsibility

The SQR Manager will be responsible for ensuring compliance with regulations and implementing the Quality Management System correctly. They will provide support and advice to the organization, coordinate inspections and audits, and perform internal and supplier audits. The successful candidate will also be responsible for document control, CAPA, Change Control, Complaints, and Non-Conformances. They should have a BSc or higher degree, verbal and written English proficiency, and the ability to pass a background check. The successful candidate must have knowledge of Regulation (EU) 2017/745, US 21 CFR Part 820, ISO 13485:2016, and ISO 27001.

  • Stockholm, Stockholm, Sweden TN Sweden Full time

    Job DescriptionIn this role as Project Management Expert - Medical Devices, you will be responsible for leading the development of complex medical devices from concept to commercialization. Your primary focus will be on driving project progress and mitigating risks while ensuring alignment with business objectives and regulatory requirements.Key...


  • Stockholm, Stockholm, Sweden Nordberg Medical Full time

    Nordberg Medical is committed to fostering a collaborative environment that encourages innovation and creativity. As a Manufacturing Optimization Expert, you will play a key role in driving the development, optimization, and validation of our manufacturing processes for implantable Class III medical devices.This role requires around 5-8 years of experience...


  • Stockholm, Stockholm, Sweden Elekta AB Full time

    Elektas MissionAt Elektas, we are driven by a higher purpose – hope for everyone dealing with cancer. Our mission is to make cancer treatment more efficient, effective, and accessible to all.Job DescriptionWe are seeking a talented and experienced Senior Software Development Engineer to join our team. As a key member of our cross-functional team, you will...


  • Stockholm, Stockholm, Sweden TN Sweden Full time

    We are seeking a highly skilled Product Quality Manager to oversee our quality assurance processes in Stockholm. The successful candidate will have a proven track record of ensuring compliant and efficient processes within their previous organisations.ResponsibilitiesEvaluate and qualify new suppliers to ensure they meet our quality standards.Develop and...


  • Stockholm, Stockholm, Sweden Nordberg Medical Full time

    We are seeking a highly skilled Implantable Device Manufacturing Specialist to join our team and drive the development, optimization, and validation of our manufacturing processes for implantable Class III medical devices. This role will require around 5-8 years of experience in process engineering within the pharmaceutical or medical device industry, with...


  • Stockholm, Stockholm, Sweden Nordberg Medical AB Full time

    Job SummaryWe are seeking a highly skilled Senior Production Process Engineer to lead and support the development, optimization, and validation of manufacturing processes for our medical devices.This role involves working closely with cross-functional teams to implement advanced manufacturing techniques and drive continuous improvement initiatives to enhance...


  • Stockholm, Stockholm, Sweden TN Sweden Full time

    At TN Sweden, we're on a mission to make life-saving technology accessible for more people.We exist to develop innovative medical devices that improve the user experience of healthcare professionals and patients worldwide.Job OverviewThis is an exciting opportunity to join our dynamic team as a User Experience Specialist for Medical Devices.You will play a...


  • Stockholm, Stockholm, Sweden Getinge Full time

    Usability Expert OpportunityWe are seeking an experienced Usability Expert for Anesthesia Devices to join our dynamic team at Getinge. As a key member of our usability team, you will be responsible for ensuring that our anesthesia devices meet the highest standards of usability, safety, and effectiveness.About the RoleAs a Usability Expert for Anesthesia...


  • Stockholm, Stockholm, Sweden TN Sweden Full time

    We are seeking a highly skilled Medical Device Implementation Specialist to join our team at TN Sweden. As a key member of the implementation project and service team, you will be responsible for servicing and implementing Patient Monitoring solutions at customer sites.The main goal of your role is to ensure successful implementations and positive customer...


  • Stockholm, Stockholm, Sweden TN Sweden Full time

    Role Summary:We are seeking an experienced clinical professional to join our team as a Medical Device Strategist. As a key member of our product management team, you will be responsible for developing and executing clinical strategies to support the launch and growth of our ventilation platform.Key Responsibilities:Develop and execute clinical validation...


  • Stockholm, Stockholm, Sweden Philips Full time

    About the JobWe are seeking a highly skilled Medical Device Field Service Technician to join our team. As a key member of our implementation project and service team, you will be responsible for servicing and implementing Patient Monitoring solutions at our customer sites.Your primary goal will be to ensure successful implementations and positive customer...


  • Stockholm, Stockholm, Sweden TN Sweden Full time

    We're looking for a talented Field Technical Engineer to join our Abbott Electrophysiology Division in Sweden.In this role, you will be responsible for providing expert technical support and advice to our clients, attending implants, follow-ups, and supporting any issues related to high voltage and low voltage stimulation devices.Main...


  • Stockholm, Stockholm, Sweden TN Sweden Full time

    Role OverviewSales Representative Neurovascular is a pivotal role at TN Sweden, responsible for promoting and selling our world-class Neurovascular product portfolio in the Swedish territory. The ideal candidate will possess strong sales experience, preferably within neurointerventional radiology and/or medical devices.Key ResponsibilitiesFamiliarize...


  • Stockholm, Stockholm, Sweden Getinge Full time

    About the RoleAs a UX Specialist at Getinge, you will play a vital role in shaping the user experience of our medical devices. With a strong focus on human-centered design, you will collaborate with cross-functional teams to create products that meet the highest standards of usability, safety, and effectiveness.The ideal candidate will have a passion for...


  • Stockholm, Stockholm, Sweden Tssab Full time

    About the CompanyAt Tssab, we're driving innovation in wearable neuromodulation medical devices. Our mission is to revolutionize healthcare through cutting-edge technology.


  • Stockholm, Stockholm, Sweden Nordberg Medical AB Full time

    ResponsibilitiesThe Senior Production Process Engineer will be responsible for leading and supporting the development, optimization, and validation of manufacturing processes for our medical devices.This role involves supporting scaling up projects, improving efficiency and product quality, and collaborating with cross-functional teams to implement advanced...


  • Stockholm, Stockholm, Sweden TN Sweden Full time

    We are looking for a highly skilled Medical Solutions Expert to join our team at TN Sweden.As a key member of the implementation project and service team, you will be responsible for servicing and implementing Patient Monitoring solutions at our customer sites.The main goal of your role is to ensure successful implementations and positive customer...


  • Stockholm, Stockholm, Sweden Tssab Full time

    Key ResponsibilitiesDesign and implement hardware for a medical electrical stimulator device, focusing on:PCB Design & Layout: Ensure BLE functionality, signal integrity, and regulatory compliance.Schematic Capture & Component Selection: Suit components to medical device standards.Manufacturing Oversight: Manage PCB manufacturing, vendor coordination, and...


  • Stockholm, Stockholm, Sweden Nordberg Medical AB Full time

    Job DescriptionWe are seeking an experienced Senior Production Process Engineer to lead and support the development, optimization, and validation of manufacturing processes for our medical devices.This role involves supporting scaling up projects, improving efficiency and product quality, and collaborating with cross-functional teams to implement advanced...


  • Stockholm, Stockholm, Sweden Getinge Full time

    Job OverviewWe are seeking a highly skilled Medical Device User Experience Specialist to join our dynamic team at Getinge. As a critical care UX engineer, you will play a crucial role in shaping the user experience of our medical devices, ensuring they meet the highest standards of usability, safety, and effectiveness.About UsGetinge provides hospitals and...