Medical Device and Pharmaceutical Regulatory Consultant

3 days ago


Cambridge, United Kingdom LennTech Search Full time
About the Role

We are seeking an experienced Regulatory Affairs Consultant to provide support for various projects, including device development and CMC activities. The successful candidate will have experience in regulatory affairs, particularly in the medical device and pharmaceutical industries, and possess strong knowledge of regulations and guidelines governing these fields.

Key Responsibilities
  • Provide regulatory support to the O1 Device Development (DD) team, including final review, comment, and approval of device-related technical documentation.
  • Offer regulatory CMC support to the Pharmaceutical Development (PD) team, encompassing the review and approval of pharm dev protocols and reports, SPECs, justifications of specs, shelf life justifications, QTPP, batch manufacture documents, Product History File, Technical Risk Assessments, Product Specification File, Product Specification Index, QTAs, labelling and packaging text.
  • Review CCRs raised by other functions, assessing their impact on regulatory submissions and approving them accordingly.
  • Examine device and CMC related information in Clinical Documents: Clinical Protocol, Pharmacy Manual, Investigator's Brochure.
Benefits
  • Opportunity to work with a leading search firm in the medical device and pharmaceutical industries.
  • Chance to contribute to the success of our clients.
  • Remote work arrangement.


  • Cambridge, United Kingdom CV-Library Full time

    Regulatory Affairs Consultant Fully Remote 3-6 Months Hourly Rate Qualifications/Skills Experienced in supporting development projects and has worked on drug device combination products and has knowledge of CMC and Device requirements (on this occasion someone with at least 60% CMC and 40% Device) and a fast learner. Below a very top-level list (can...


  • Cambridge, United Kingdom LennTech Search Full time

    Regulatory Affairs Consultant Fully Remote 3-6 Months Hourly Rate Qualifications/Skills Experienced in supporting development projects and has worked on drug device combination products and has knowledge of CMC and Device requirements (on this occasion someone with at least 60% CMC and 40% Device) and a fast learner. Below a very top-level list (can...


  • Cambridge, Cambridgeshire, United Kingdom Indo Search Full time

    Medical Device Regulatory LeaderThis is a unique opportunity to lead our regulatory affairs team in a fast-paced and innovative environment at the forefront of medical technology. We are an award-winning developer of high-end, complex medical technologies.About the Role:Lead a team of experienced regulatory professionals to develop and implement global...


  • Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Full time

    **Newton Colmore Consulting: A Specialist Recruitment Company in the Medical Devices Sector**We are currently seeking a highly skilled Medical Devices Mechanical Engineer to join our team. Based in South Cambridgeshire, this role will involve utilizing SolidWorks for the CAD design of new Medical Devices.The ideal candidate will have a strong background in...


  • Cambridge, United Kingdom Newton Colmore Consulting Ltd Full time

    Medical Devices Mechanical Engineer - SolidWorks - Cambridge A growing Medical Devices group are currently looking for a Mechanical Design Engineer who can help with the development of life saving Medical Devices. Based in South Cambridgeshire, you will be using SolidWorks for the CAD design of new Medical Devices. You will be working alongside inventors,...


  • Cambridge, United Kingdom LennTech Search Full time

    Job DescriptionWe are seeking an experienced Regulatory Affairs Consultant to join our team at LennTech Search. This is a fully remote position that requires 3-6 months of commitment with an hourly rate.Key ResponsibilitiesProvide regulatory support to the O1 Device Development (DD) team, including final review, comment, and approval of device-related...


  • Cambridge, United Kingdom Newton Colmore Consulting Ltd Full time

    Electronics Engineer Consultant - Medical Devices - Cambridge Due to the development of a range of electro-mechanical Medical Devices, we are currently looking for an Electronics Engineer who has worked on the successful design of Medical Devices in the past. You will be based in a team of Medical Devices experts, based in Cambridge, and work on inventing...


  • Cambridge, United Kingdom Newton Colmore Consulting Ltd Full time

    Medical Devices Consultant - Senior Mechanical Engineer - Cambridge Due to the growth of a leading Medical Devices organisation, we are currently looking for a Senior Mechanical Engineer, Project Manager, Medical Devices Inventor or Mechanical Design Consultant for a newly signed off role. The company is based in Cambridgeand have some of the most...


  • Cambridge, Cambridgeshire, United Kingdom Vectura Group Full time

    Job DescriptionWe are seeking a highly skilled Device Regulatory Expert to join our regulatory affairs team at Vectura Group. As a key member of our team, you will be responsible for ensuring compliance with global regulations and guidelines for medical devices and drug-device combination products.Key Responsibilities:Regulatory Leadership: Assume the role...


  • Cambridge, United Kingdom Appcastenterprise Full time

    Team Consulting is an employee-owned, award-winning device design and development consultancy. We focus solely on medical devices, supporting international clients from large pharmaceutical companies to start ups. As part of the device testing team, youwill be working in our high-tech labs and workshop spaces which are set within our 17th Century barn in the...


  • Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full time

    Senior Mechanical Engineer - Medical DevicesWe are looking for a Senior Mechanical Engineer to lead our Medical Devices group at Newton Colmore Consulting Ltd.You will collaborate with cross-functional teams to develop medical devices, utilizing SolidWorks for CAD design, and have hands-on engineering skills, including jig assembly, testing, and instrument...


  • Cambridge, Cambridgeshire, United Kingdom Russell Tobin Full time

    OverviewRussell Tobin is seeking a talented Medical Device Development Lead to join our team. As a key member of our team, you will be responsible for leading design control and risk management activities for combination product development programs. This role requires a strong background in quality assurance and a proven track record of delivering...


  • Cambridge, Cambridgeshire, United Kingdom Russell Tobin Full time

    We are recruiting for a Medical Device Development Manager to join our team in Cambridge, UK.Job ResponsibilitiesThis is a senior role that requires a highly experienced individual to lead design control and risk management activities for combination product development programs. The successful candidate will ensure deliverables are appropriately authored,...


  • Cambridge, Cambridgeshire, United Kingdom Arete Medical Technologies Full time

    Job Title: Biomedical Engineering SpecialistLocation: Cambridge, UKJob Type: Full-timeAbout Us:Arete Medical Technologies is a leading developer of connected diagnostic and monitoring devices for precision management of respiratory conditions. We are committed to delivering high-quality products that improve patient outcomes and experiences.Role...


  • Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Full time

    About the Role:Newton Colmore Consulting is seeking an exceptional Medical Devices Development Specialist to join our team in Cambridge. This exciting opportunity involves working closely with our Quality Assurance and Regulatory Affairs department to develop innovative medical devices.Your Key Responsibilities:Device Development: Collaborate with our R&D...


  • Cambridge, United Kingdom Newton Colmore Full time

    Medical Devices Consultant - Senior Mechanical Engineer - Cambridge Due to the growth of a leading Medical Devices organisation, we are currently seeking a Senior Mechanical Engineer, Project Manager, Medical Devices Inventor, or Mechanical Design Consultant for a newly approved role. The company is based in Cambridge and boasts some of the most impressive...


  • Cambridge, United Kingdom CV-Library Full time

    Medical Devices Consultant - Senior Mechanical Engineer - Cambridge Due to the growth of a leading Medical Devices organisation, we are currently seeking a Senior Mechanical Engineer, Project Manager, Medical Devices Inventor, or Mechanical Design Consultant for a newly approved role. The company is based in Cambridge and boasts some of the most impressive...


  • Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full time

    Medical Devices Mechanical Design EngineerWe are seeking an experienced Mechanical Design Engineer to join our team at Newton Colmore Consulting Ltd, collaborating in the development of life-saving medical devices.This role involves a combination of computer-aided design and hands-on engineering skills, utilizing SolidWorks for CAD design. You will work...


  • Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Full time

    Are you a skilled Mechanical Design Engineer with experience in SolidWorks? We have an exciting opportunity for you to join our team at Newton Colmore Consulting as a Medical Devices Design Engineer.We are looking for a talented individual to assist in the development of life-saving medical devices based in South Cambridgeshire. As a key member of our team,...


  • Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Full time

    Biotech Medical Devices Developer PositionLocation: CambridgeNewton Colmore Consulting is recruiting a skilled developer to work on the creation of software for electro-mechanical devices used in the biotech and medical devices sectors.Responsibilities:Collaborate with cross-functional teams to develop cutting-edge medical devices.Ensure adherence to...