Regulatory Affairs Specialist for Medical Devices

vor 1 Woche


Bulle FR, Freiburg, Schweiz UCB Vollzeit
Medical Device Regulatory Scientist Opportunity

We are seeking a highly skilled Medical Device Regulatory Scientist to join our Global Regulatory Affairs team in Brussels, Bulle, or Slough.

This role involves regulating activities for marketed and development medical devices and combinations products within the Neurology, Immunology, and New Medicines units.

Key responsibilities include:

  • Developing and implementing global regulatory strategies to achieve timely approvals for device constituents of combination products.
  • Preparing and maintaining Technical Documentation Files for CE Marks, NBs Opinions, and FDA clearance.
  • Interacting with Health Authorities and supporting the global CMC regulatory strategy.
  • Identifying required supporting devices documents and negotiating their delivery within project timelines.
  • Maintaining regulatory compliance through Life Cycle Management support.

To succeed in this role, you will need:

  • Bachelor's degree.
  • Knowledge of drugs/medical devices manufacturing processes.
  • Understanding of GMP/ISO requirements and standard systems.
  • Expertise in IVD, MDR, 510K, and IMDRF requirements.
  • Able to contribute to cross-functional teams and operate within a matrix organizational structure.
  • Ability to synthesize technical information and author medical devices technical documentation.
  • Knowledge of drug delivery products.

UCB offers a dynamic and collaborative work environment. If you are passionate about regulatory affairs and committed to making a difference in patients' lives, we encourage you to apply.



  • Bulle FR, Freiburg, Schweiz Randstad Vollzeit

    Job Opportunity:UCB is seeking a highly skilled Administrative Compliance Specialist to join their Medical Affairs department. As a key member of the team, you will be responsible for ensuring transparency and compliance within the Alps region. Your primary focus will be on implementing, maintaining, and optimizing the transparency process, as well as...


  • Bulle FR, Freiburg, Schweiz Randstad Vollzeit

    Job DescriptionUCB is seeking a highly skilled Administrative Compliance Specialist to join their Medical Affairs department in the Alps region. As a key member of the team, you will be responsible for ensuring transparency and compliance within the region.Key Responsibilities:Implement and maintain transparency processes to ensure compliance with regulatory...


  • Bulle FR, Freiburg, Schweiz UCB Vollzeit

    Job Overview We are seeking a Quality Operations QA Specialist to join our team at UCB. Role Responsibilities As a Quality Operations QA Specialist, you will be responsible for compliance activities and quality strategies related to product delivery. This includes activities and processes such as deviation management, process validation, and...


  • Bulle FR, Freiburg, Schweiz Randstad Vollzeit

    Job OpportunityRandstad is seeking a highly skilled Administrative Compliance Specialist to join our team in the Medical Affairs department. This is a fantastic opportunity to work on a transparency project within the Alps region, covering Switzerland and Austria.Key Responsibilities:Implement, maintain, and optimize transparency processes;Ensure timely and...


  • Bulle FR, Freiburg, Schweiz UCB Vollzeit

    About the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at UCB.As a Quality Assurance Specialist, you will be responsible for ensuring compliance with national and international regulations, guidelines, and UCB Quality Policies.Key ResponsibilitiesProvide quality support related to product delivery, including management of...


  • Bulle FR, Freiburg, Schweiz UCB Vollzeit

    About the RoleAs a Quality Operations QA Specialist at UCB, you will play a critical role in ensuring compliance with national and international regulations, guidelines, and quality policies. Your responsibilities will include managing compliance activities and quality strategies related to product delivery, from start to finish.Key ResponsibilitiesProvide...


  • Bulle FR, Freiburg, Schweiz UCB Vollzeit

    About the RoleAs a Quality Operations QA Specialist at UCB, you will be responsible for ensuring compliance with national and international regulations, guidelines, and quality policies related to product delivery. Your key responsibilities will include:Providing quality support for product delivery from start to finish, including management of activities...


  • Bulle FR, Freiburg, Schweiz UCB Vollzeit

    About the RoleAs a Quality Operations QA Specialist at UCB, you will play a critical role in ensuring compliance with national and international regulations, guidelines, and quality policies. Your responsibilities will include managing compliance activities and quality strategies related to product delivery, from production to supply chain, technical...


  • Bulle FR, Freiburg, Schweiz UCB Vollzeit

    About the RoleAs a Quality Assurance Specialist at UCB, you will play a critical role in ensuring the quality and compliance of our pharmaceutical products. Your responsibilities will include:Providing quality support for product delivery, from start to finish, including management of activities and processes related to deviations, OOS, CAPAs, Change...


  • Bulle FR, Freiburg, Schweiz UCB Vollzeit

    About the role As a Quality Operations Specialist, your key responsibilities include ensuring compliance with national and international regulations, guidelines (GMP), and relevant UCB Quality Policies related to product delivery (Production, Supply Chain, Technical Services, Quality Operations, Business Acceleration, HSE&Q). Key responsibilities ...


  • Bulle FR, Freiburg, Schweiz UCB Vollzeit

    About the RoleAs a Quality Assurance Specialist at UCB, you will play a critical role in ensuring the quality and compliance of our products. Your responsibilities will include:Providing quality support related to product delivery from start to finish, including management of activities and processes related to deviations, OOS, CAPAs, Change Control,...


  • Bulle FR, Freiburg, Schweiz UCB Vollzeit

    About the RoleAs a Quality Operations QA Specialist at UCB, you will be responsible for ensuring compliance with national and international regulations, guidelines (GMP), and relevant UCB Quality Policies. Your key focus will be on quality strategies related to product delivery, including management of activities and processes related to deviations, OOS,...


  • Bulle FR, Freiburg, Schweiz Randstad Vollzeit

    Job DescriptionWe are seeking a highly skilled Marketing Specialist to join our team at Randstad. The ideal candidate will have a strong background in marketing, with a focus on rare diseases and epilepsy.Your mission:Develop and implement a marketing strategy for rare diseases and epilepsy, aligned with our company's goals and objectives;Collaborate with...


  • Bulle FR, Freiburg, Schweiz Randstad Vollzeit

    Job DescriptionWe are seeking a highly skilled Marketing Specialist to join our team at Randstad. The ideal candidate will be responsible for driving the localization and implementation of the EU and regional Rare & Epilepsy strategy and action plan in alignment with our Alps Rare&Epi Lead and Alps Marketing Lead.Your mission will be to develop local...


  • Bulle FR, Freiburg, Schweiz UCB Vollzeit

    About the RoleAs a Quality Operations QA Specialist, you are responsible for ensuring compliance with national and international regulations, guidelines, and UCB Quality Policies. Your key tasks include:Providing quality support for product delivery from start to finish, including deviation management, CAPAs, and quality reviews.Establishing and maintaining...

  • Automation Specialist

    vor 3 Wochen


    Ecublens FR, Freiburg, Schweiz Oratek SA Vollzeit

    Oratek SA, a Swiss engineering consulting firm, is seeking a highly skilled and motivated professional to join our dynamic team as an Automation Specialist.We are a multidisciplinary team that thrives on tackling complex challenges and delivering cutting-edge solutions in the Computers and Electronics Manufacturing industry.As an Automation Specialist at...

  • Operations Specialist

    vor 1 Woche


    Bulle FR, Freiburg, Schweiz Gruyère Energie SA Vollzeit

    As an Operations Specialist, you will be responsible for coordinating projects and managing processes to ensure seamless execution.Key responsibilities include:Project planning: Develop and implement project plans to meet business objectives.Process improvement: Identify opportunities to improve efficiency and streamline processes.Team collaboration: Work...

  • Accountant Specialist

    vor 1 Woche


    Bulle FR, Freiburg, Schweiz Gruyère Energie SA Vollzeit

    Job DescriptionAbout the Role: We are seeking a highly skilled and experienced Accountant Specialist to join our team. The ideal candidate will possess a strong background in financial analysis, auditing, and accounting principles.Key Responsibilities:* Conduct financial analysis and prepare financial reports* Develop and implement financial models and...

  • Marketing Specialist

    vor 1 Woche


    Bulle FR, Freiburg, Schweiz LANDI Moléson-Sarine SA Vollzeit

    About Brand DevelopmentWe are seeking a skilled Marketing Specialist to join our team and drive brand growth through innovative marketing strategies.Key Responsibilities:Develop and implement marketing campaigns to increase brand awarenessCollaborate with the sales team to drive revenue growthAnalyze market trends and adjust marketing strategies...

  • Marketing Specialist

    vor 1 Woche


    Bulle FR, Freiburg, Schweiz Dosim Vollzeit

    Key Responsibilities:• Develop and implement brand development strategies to expand our product offerings• Collaborate with cross-functional teams to drive brand growth and expansion• Analyze market trends and consumer behavior to inform marketing decisionsAbout the Role:We are seeking a skilled Marketing Specialist to join our team and contribute to...