Regulatory Affairs Coordinator

3 days ago


Stockholm, Stockholm, Sweden RaySearch Laboratories AB (publ) - Stockholm Full time
Career Opportunity

We are seeking a highly motivated and experienced QA/RA Specialist to join our team. As a key member of our department, you will play a crucial role in ensuring the quality and regulatory compliance of our medical devices.

Responsibilities:
  1. Manage the transition of our Quality Management System (QMS) from one digital platform to another.
  2. Coach the organization on CAPA management and lead internal audits, external audits, and inspections.
Requirements:
  • Project management experience.
  • Knowledge of ISO 13485, MDR, or QSR.
  • Flexible and structured approach to work.


  • Stockholm, Stockholm, Sweden POC Full time

    Regulatory Compliance and Sustainability ExpertWe are seeking a highly experienced Environmental and Regulatory Affairs Expert to join our team. The successful candidate will have a deep understanding of sustainability frameworks, regulatory requirements, and industry standards.Responsibilities include:Ensuring compliance with global consumer product...


  • Stockholm, Stockholm, Sweden Bondi Chefrekrytering AB Full time

    We are recruiting a Head of Regulatory Affairs to lead our EU Regulatory Affairs team in the Nordic markets. As a key member of our team, you will be responsible for post-approval/life-cycle Regulatory activities.About the RoleIn this role, you will have the opportunity to develop and implement regulatory strategies, ensuring alignment with company...


  • Stockholm, Stockholm, Sweden Karo Group Full time

    Karo Group is a dynamic and innovative company dedicated to empowering people to make informed healthcare decisions.About the RoleWe are seeking an experienced Regulatory Affairs Lead to join our team in Stockholm, Sweden. As a key member of our Global Regulatory Affairs department, you will play a vital role in ensuring compliance with regulatory...


  • Stockholm, Stockholm, Sweden Bondi Chefrekrytering AB Full time

    Are you passionate about improving patient lives?Bondi Chefrekrytering AB is seeking a highly motivated Senior Regulatory Affairs Manager to join our team. As part of the EU Regulatory Affairs team, you will be responsible for post-approval/life-cycle Regulatory activities in the Nordic markets.Main ResponsibilitiesAct as point of contact with Nordics...


  • Stockholm, Stockholm, Sweden Bondi Chefrekrytering AB Full time

    Company Overview:Bondi Chefrekrytering AB is a leading Swedish medtech company with high potential, committed to innovation and excellence.Job Summary:We are seeking a highly skilled Senior RA Specialist Med Tech to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with laws and regulations...


  • Stockholm, Stockholm, Sweden Business Sweden Full time

    About UsBusiness Sweden is a government agency working to increase export opportunities for Swedish businesses. We provide strategic advice and hands-on support to companies of all sizes and in a wide range of industries, both locally and internationally.About the RoleWe are seeking a highly skilled International Regulatory Affairs Specialist to join our...


  • Stockholm, Stockholm, Sweden PharmaRelations ApS Full time

    Leadership OpportunityAs Senior Director Regulatory Affairs, you will have the opportunity to lead regulatory activities, develop and implement strategies, and collaborate with the global team. You will take ownership of regulatory activities, overseeing marketing and ensuring compliance.AccountabilitiesTake ownership of regulatory activities, including MAs,...


  • Stockholm, Stockholm, Sweden PharmaRelations ApS Full time

    OverviewPharmaRelations ApS is seeking an experienced Senior Director Regulatory Affairs to lead regulatory strategies, particularly for OTC products. This is a key role in building a new pharmaceutical portfolio.ResponsibilitiesEstablish and lead regulatory activities across areas including MAs, marketing of cosmetics, medical devices, and food...


  • Stockholm, Stockholm, Sweden Karo Healthcare Full time

    Key ResponsibilitiesPersonnel Management: Oversee the Submissions & Compliance group, providing guidance and support to team members.Team Development: Ensure a dedicated and motivated team drives maintenance and development of Karo medicinal products.Resource Allocation: Manage resources effectively to meet business objectives.Strategic Planning: Develop and...


  • Stockholm, Stockholm, Sweden QBtech AB Full time

    **About Us**QBtech AB is a dynamic and innovative company dedicated to improving lives through cutting-edge technology. We offer a unique opportunity to work with a talented team of experts who share a passion for transforming healthcare. If you are a driven and results-oriented individual with a keen interest in quality and regulatory affairs, we encourage...


  • Stockholm, Stockholm, Sweden PharmaRelations ApS Full time

    PharmaRelations ApS, a pioneering leader in the consumer health space, is expanding into the pharmaceutical industry. We are seeking an experienced Senior Director to establish and lead regulatory strategies for OTC products as we build our pharmaceutical portfolio.This role offers the opportunity to shape the future of OTC pharmaceuticals for a company...


  • Stockholm, Stockholm, Sweden Raysearch Laboratories AB (Publ) Full time

    Job DescriptionWe are seeking a highly skilled QA/RA Specialist to join our team. As a key member of our Quality Assurance and Regulatory Affairs department, you will play a crucial role in ensuring the accuracy and reliability of our medical device software. Your primary responsibilities will include managing QMS transitions, CAPA processes, and...


  • Stockholm, Stockholm, Sweden Bondi Chefrekrytering AB Full time

    We are looking for a skilled Regulatory Lead Nordics to support our EU Regulatory Affairs team. In this role, you will be responsible for post-approval/life-cycle Regulatory activities in the Nordic markets.About the RoleThis position requires strong communication skills, ability to gain respect and influence external experts, and build lasting relationships...


  • Stockholm, Stockholm, Sweden SEB group Full time

    Job SummaryWe're seeking a seasoned professional to join our Corporate and Investment Banking division as a Business Regulatory Consultant. This exciting opportunity will leverage your expertise in regulatory affairs, compliance, or a related field to drive end-to-end client communication related to global markets regulations.Key ResponsibilitiesManage...


  • Stockholm, Stockholm, Sweden Thor Companies Full time

    Medical Affairs Position OverviewThor Companies is recruiting a highly skilled Global Pharmaceutical Affairs Specialist to join our team. In this role, you will play a crucial part in shaping the future of medical affairs and contribute to the success of our company.You will be responsible for driving strategic leadership for medical affairs, collaborating...


  • Stockholm, Stockholm, Sweden Thor Companies Full time

    Thor CompaniesAs a leading player in the pharmaceutical industry, Thor Companies is committed to shaping the future of medical affairs. We are currently seeking an experienced Medical Affairs Leadership Manager to play a key role in driving strategic leadership for medical affairs in the region.The successful candidate will collaborate with key opinion...


  • Stockholm, Stockholm, Sweden PharmaRelations ApS Full time

    About the Role:We are seeking an experienced Sr Director Regulatory Affairs to join our team at PharmaRelations ApS. As a strategic leader in regulatory affairs, you will take ownership of regulatory activities across a range of areas, including MAs (MRP/DCP and national licenses), and oversee the marketing of cosmetics, medical devices, and food supplements...


  • Stockholm, Stockholm, Sweden PharmaRelations ApS Full time

    About the RoleWe are looking for a strategic leader in regulatory affairs to shape the future of OTC pharmaceuticals. As Senior Director Regulatory Affairs, you will take ownership of regulatory activities, oversee marketing, and ensure compliance.Key AccountabilitiesTake ownership of regulatory activities, including MAs, marketing of cosmetics, medical...


  • Stockholm, Stockholm, Sweden Karo Group Full time

    Karo Group is committed to making intelligent health decisions through innovation and expertise.About the RoleWe are seeking an experienced Global Regulatory Compliance Officer to join our team in Stockholm, Sweden. As a key member of our Global Regulatory Affairs department, you will play a vital role in ensuring compliance with regulatory requirements and...


  • Stockholm, Stockholm, Sweden Bondi Chefrekrytering AB Full time

    Bondi Chefrekrytering AB seeks a highly experienced Nordic Regulatory Expert to join our EU Regulatory Affairs team. This role involves post-approval/life-cycle Regulatory activities in the Nordic markets.Key ResponsibilitiesAct as point of contact with Nordics Regulatory Authorities and internal/external stakeholders.Ensure timely updated catalogue texts...