Medical Device Regulatory Specialist

6 days ago


Slough, Slough, United Kingdom UCB Full time

Make a Lasting Impact on Patient Care


We are seeking a highly skilled Medical Device Regulatory Specialist to join our Global Regulatory Affairs team at UCB. This role will be based in one of our European offices, including Brussels (Belgium), Bulle (Switzerland), or Slough (UK).

The Medical Device Regulatory Specialist will be responsible for regulatory activities for marketed and development medical devices and combination products within the scope of the Neurology, Immunology, and New Medicines units.

Key Responsibilities:

  • Develop and implement global regulatory strategies for device constituents of combination products, ensuring timely approvals to meet business needs.
  • Prepare and maintain Technical Documentation Files to obtain CE Marks, NBs Opinions, and/or FDA clearance for assigned projects.
  • Collaborate with Health Authorities to ensure regulatory compliance.
  • Support the global CMC regulatory strategy for assigned projects/products, ensuring consistency with global regulatory affairs practice, missions, goals, and objectives.
  • Identify and negotiate the delivery of approved technical source documents in accordance with project timelines.
  • Ensure Life Cycle Management support to maintain regulatory compliance of approved devices.

Requirements:

  • Bachelor's degree in a relevant field.
  • Knowledge of drugs/medical devices manufacturing processes.
  • Understanding of GMP/ISO requirements and standard systems.
  • Knowledge of IVD, MDR, 510K, IMDRF requirements.
  • Proven ability to contribute to cross-functional teams and operate within a matrix organizational structure.
  • Ability to synthesize technical information and data to author medical devices technical documentation, CTD Module 3, and briefing books.
  • Knowledge of drug delivery products.

UCB is a global biopharmaceutical company dedicated to the discovery and development of innovative medicines and solutions to transform patients' lives. If you are passionate about making a difference in the lives of patients, we encourage you to apply for this exciting opportunity.



  • Slough, Slough, United Kingdom UCB Full time

    Make a Lasting Impact on Patient CareWe are seeking a highly skilled Medical Device Regulatory Specialist to join our Global Regulatory Affairs team at UCB. This role will be based in one of our European offices, including Brussels (Belgium), Bulle (Switzerland), or Slough (UK).The Medical Device Regulatory Specialist will be responsible for regulatory...


  • Slough, Slough, United Kingdom UCB Full time

    Make a Lasting Impact on Patient CareWe are seeking a highly skilled Medical Device Regulatory Specialist to join our Global Regulatory Affairs team at UCB. This role will be based in one of our European offices, including Brussels (Belgium), Bulle (Switzerland), or Slough (UK).The Medical Device Regulatory Specialist will be responsible for regulatory...


  • Slough, Slough, United Kingdom UCB Full time

    Make a Lasting Impact on Patient CareWe are seeking a highly skilled Medical Device Regulatory Specialist to join our Global Regulatory Affairs team at UCB. This role will be based in one of our European offices, including Brussels (Belgium), Bulle (Switzerland), or Slough (UK).The Medical Device Regulatory Specialist will be responsible for regulatory...


  • Slough, Slough, United Kingdom UCB Full time

    Make a Lasting Impact on Patient CareWe are seeking a highly skilled Medical Device Regulatory Specialist to join our Global Regulatory Affairs team at UCB. This role will be based in one of our European offices, including Brussels (Belgium), Bulle (Switzerland), or Slough (UK).The Medical Device Regulatory Specialist will be responsible for regulatory...


  • Slough, Slough, United Kingdom BMS Performance Full time

    About the RoleWe are seeking an experienced Medical Device Sales Professional to join our team as a Strategic Business Development Manager at BMS Performance. This is an exciting opportunity to develop a specialist business unit within our existing company structure.About the CompanyBMS Performance is a leading provider of niche medical devices, experiencing...


  • Slough, Slough, United Kingdom Premier Group Recruitment Full time

    Job Title: Senior Mechanical Design Engineer - Medical DevicesJob Summary:Premier Group Recruitment is seeking a highly skilled Senior Mechanical Design Engineer to join our client's team in Slough. As a Senior Mechanical Design Engineer, you will be responsible for leading the design and development of medical devices, working closely with cross-functional...


  • Slough, Slough, United Kingdom Premier Group Recruitment Full time

    Job Title: Senior Mechanical Design Engineer - Medical DevicesJob Summary:Premier Group Recruitment is seeking a highly skilled Senior Mechanical Design Engineer to join our client's team in Slough. As a Senior Mechanical Design Engineer, you will be responsible for leading the design and development of medical devices, working closely with cross-functional...


  • Slough, Slough, United Kingdom Redshore Full time

    Job SummaryRedshore is seeking a highly skilled Quality Systems Engineer to join its team in Slough. As a Quality Systems Engineer, you will be responsible for the management, development, implementation, and continual improvement of an efficient and effective Quality Management System (QMS).Key ResponsibilitiesPlan and conduct internal quality audits (EN...


  • Slough, Slough, United Kingdom Redshore Full time

    Job SummaryRedshore is seeking a highly skilled Quality Systems Engineer to join its team in Slough. As a Quality Systems Engineer, you will be responsible for the management, development, implementation, and continual improvement of an efficient and effective Quality Management System (QMS).Key ResponsibilitiesPlan and conduct internal quality audits (EN...


  • Slough, Slough, United Kingdom Pharmiweb Full time

    Clinical Drug Delivery Device LeadPharmiweb is seeking a skilled Clinical Drug Delivery Device Lead to join our team. This role requires a professional to define and implement strategies for drug delivery devices used in clinical trials.As a Clinical Drug Delivery Device Lead, you will collaborate with a cross-functional team to ensure timely support and...


  • Slough, Slough, United Kingdom Ernest Gordon Recruitment Full time

    Job Title: Medical Equipment TechnicianJob Type: Full-timeIndustry: Medical DevicesLocation: Reading, Slough, LutonJob Description:We are seeking a skilled Medical Equipment Technician to join our team at Ernest Gordon Recruitment. As a Medical Equipment Technician, you will be responsible for installing, testing, and maintaining medical equipment in...


  • Slough, Slough, United Kingdom Ernest Gordon Recruitment Full time

    Job Title: Medical Equipment TechnicianJob Type: Full-timeIndustry: Medical DevicesLocation: Reading, Slough, LutonJob Description:We are seeking a skilled Medical Equipment Technician to join our team at Ernest Gordon Recruitment. As a Medical Equipment Technician, you will be responsible for installing, testing, and maintaining medical equipment in...


  • Slough, Slough, United Kingdom Pro4orm People Ltd Full time

    Job DescriptionWe are seeking an experienced Regulatory Affairs professional to join our team at Pro4orm People Ltd. As a dynamic and fast-growing business, we are looking for a talented individual to take on the role of Regulatory Affairs Manager.This is a challenging opportunity for a skilled Regulatory Affairs professional to take responsibility for and...


  • Slough, Slough, United Kingdom Pro4orm People Ltd Full time

    Job DescriptionWe are seeking an experienced Regulatory Affairs professional to join our team at Pro4orm People Ltd. As a dynamic and fast-growing business, we are looking for a talented individual to take on the role of Regulatory Affairs Manager.This is a challenging opportunity for a skilled Regulatory Affairs professional to take responsibility for and...


  • Slough, Slough, United Kingdom Pro4orm People Ltd Full time

    Job DescriptionWe are seeking an experienced Regulatory Affairs professional to join our team at Pro4orm People Ltd. Our client is a dynamic and fast-growing business with a strong entrepreneurial spirit and a pipeline of exciting opportunities.The Regulatory Affairs Manager will be responsible for executing various regulatory activities related to the EMEA...


  • Slough, Slough, United Kingdom Pro4orm People Ltd Full time

    Job DescriptionWe are seeking an experienced Regulatory Affairs professional to join our team at Pro4orm People Ltd. Our client is a dynamic and fast-growing business with a strong entrepreneurial spirit and a pipeline of exciting opportunities.The Regulatory Affairs Manager will be responsible for executing various regulatory activities related to the EMEA...


  • Slough, Slough, United Kingdom Pro4orm People Ltd Full time

    Job DescriptionWe are seeking an experienced Regulatory Affairs professional to join our team at Pro4orm People Ltd. Our client is a dynamic and fast-growing business with a strong entrepreneurial spirit and a pipeline of exciting opportunities.The Regulatory Affairs Manager will be responsible for executing various regulatory activities related to the EMEA...


  • Slough, Slough, United Kingdom Pro4orm People Ltd Full time

    Job Title: Regulatory Affairs ManagerWe are seeking an experienced Regulatory Affairs Manager to join our team at Pro4orm People Ltd. As a key member of our team, you will be responsible for executing various regulatory activities related to the EMEA and UK region.Key Responsibilities:Prepare, submit, and manage variation applications to agreed...


  • Slough, Slough, United Kingdom Pro4orm People Ltd Full time

    Job Title: Regulatory Affairs ManagerWe are seeking an experienced Regulatory Affairs Manager to join our team at Pro4orm People Ltd. As a key member of our team, you will be responsible for executing various regulatory activities related to the EMEA and UK region.Key Responsibilities:Prepare, submit, and manage variation applications to agreed...


  • Slough, Slough, United Kingdom Lonza Full time

    Role Overview:Fulfill responsibilities as a Regulatory Compliance Specialist as outlined in industry standardsExamine documentation pertinent to production and quality assessmentAssist Quality Assurance leadership in overseeing the Pharmaceutical Quality Management SystemOffer expertise on Quality issues for ongoing enhancementMain Responsibilities:Guarantee...