Device Regulatory Support Lead

1 day ago


StocktononTees, Stockton-on-Tees, United Kingdom Fujifilm Corporation Full time
About the Job
This position offers a unique opportunity to join a dynamic team at FUJIFILM Healthcare Americas Corporation. As a Device Regulatory Support Lead, you will play a critical role in supporting full compliance to U.S. FDA medical device regulations, ISO 13485 standard requirements, and other applicable laws. Your responsibilities will include designing responsible personnel for device marketing authorization and facility registration, preparing European Union Technical Files, and evaluating customer complaints.

About the Team
You will be working closely with a team of experienced professionals in regulatory affairs, quality assurance, research and development, and sales. Our team is passionate about delivering high-quality products and services that meet the evolving needs of healthcare professionals and patients.

Benefits
* Competitive salary range of $80,000 - $100,000 per year* Comprehensive benefits package including health insurance, retirement plan, and paid time off* Opportunities for professional growth and development* Collaborative and dynamic work environment* Recognition and rewards for outstanding performance* Occasional travel may be required based on business need* Equal Opportunity Employer* FUJIFILM is an equal opportunity and affirmative action employer committed to diversity and inclusion.

  • Stockton-on-Tees, Stockton-on-Tees, United Kingdom Fujifilm Corporation Full time

    Job DescriptionIn this role, you will provide regulatory support to FUJIFILM Healthcare Americas Corporation, ensuring full compliance to U.S. FDA medical device regulations, ISO 13485 standard requirements, and other applicable laws. Your responsibilities will include designing responsible personnel for device marketing authorization and facility...


  • Stockton-on-Tees, Stockton-on-Tees, United Kingdom Fujifilm Corporation Full time

    OverviewFUJIFILM Healthcare Americas Corporation is a leading innovator in diagnostic and enterprise imaging solutions designed to meet the evolving needs of healthcare across prevention, diagnosis, and treatment.Job Title: Regulatory Affairs SpecialistJob PurposeThis position provides Regulatory Affairs support to FUJIFILM Healthcare Americas Corporation,...


  • Stockton-on-Tees, Stockton-on-Tees, United Kingdom Fujifilm Corporation Full time

    Job OverviewFujifilm Corporation is a leading innovator in diagnostic and enterprise imaging solutions. As a Regulatory Affairs Professional, you will support full compliance to U.S. FDA medical device regulations, ISO 13485 standard requirements, and other applicable laws.About the RoleThis position requires three or more years of experience performing...


  • Stockton-on-Tees, Stockton-on-Tees, United Kingdom Fujifilm Corporation Full time

    Job Title: Regulatory Affairs SpecialistJob SummaryFujifilm Healthcare Americas Corporation is seeking a highly skilled Regulatory Affairs Specialist to provide support for medical device regulatory requirements. The successful candidate will be responsible for ensuring compliance with U.S. FDA regulations, ISO 13485 standard requirements, and other...


  • Stockton-on-Tees, Stockton-on-Tees, United Kingdom Fujifilm Corporation Full time

    Job SummaryFujifilm Healthcare Americas Corporation is seeking a highly skilled Regulatory Affairs Specialist to provide support for the company's medical device regulatory requirements. The successful candidate will be responsible for ensuring full compliance with all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulations, ISO...


  • Stockton-on-Tees, Stockton-on-Tees, United Kingdom Fujifilm Corporation Full time

    Job TitleRegulatory Affairs Specialist - Compliance ExpertAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to provide support for our company's medical device regulatory requirements. The successful candidate will have a strong understanding of U.S. FDA regulations and international standards, including ISO 13485.Key...


  • Stockton-on-Tees, Stockton-on-Tees, United Kingdom Fujifilm Corporation Full time

    Job SummaryFujifilm Healthcare Americas Corporation is seeking a highly skilled Regulatory Affairs Specialist to provide support for medical device regulatory requirements. The ideal candidate will have a strong understanding of U.S. FDA regulations and international standards.Key ResponsibilitiesDesignated Responsible Personnel for Device Marketing...


  • Stockton-on-Tees, Stockton-on-Tees, United Kingdom Fujifilm Corporation Full time

    The Regulatory Affairs Specialist role at Fujifilm Corporation is a critical position that requires a deep understanding of medical device regulations and standards. This individual will provide regulatory support to the company, ensuring full compliance with U.S. FDA requirements, ISO 13485 standard requirements, and other applicable laws and...


  • Stockton-on-Tees, Stockton-on-Tees, United Kingdom Pragmatic Full time

    Job DescriptionWe are seeking a seasoned expert in material science and device physics to lead our new Device Physics team within the R&D group. As Senior Manager Device Physics, you will be responsible for overseeing material science and device physics programs, working closely with teams across R&D, Technology, and Operations.Key ResponsibilitiesEstablish...


  • Stockton-on-Tees, Stockton-on-Tees, United Kingdom PragmatIC Semiconductor Full time

    Job OverviewPragmatIC Semiconductor is seeking a highly skilled Device Development Engineer to join its R&D team in Sedgefield. As part of the team, the successful candidate will report to the Emerging Technologies Manager and lead and support the development activities including device fabrication, metrology, and electrical test.Key ResponsibilitiesLead...


  • Stockton-on-Tees, Stockton-on-Tees, United Kingdom PragmatIC Full time

    Device Development Engineer OpportunityPragmatIC is seeking a highly skilled Device Development Engineer to join its R&D team in Sedgefield. As part of the team, the successful candidate will report to the Emerging Technologies Manager and lead device fabrication, metrology, and electrical test activities.Key ResponsibilitiesLead device fabrication,...


  • Stockton-on-Tees, Stockton-on-Tees, United Kingdom PragmatIC Semiconductor Full time

    We are PragmatIC Semiconductor, a pioneering company in the field of flexible electronics. As a senior member of our R&D team, you will play a key role in establishing a new Device Physics team to drive innovation and excellence in semiconductor materials and devices.Your primary responsibility will be to lead material science and device physics programs for...


  • Stockton-on-Tees, Stockton-on-Tees, United Kingdom North Tees & Hartlepool NHS Foundation Trust Full time

    Main duties of the roleThe role requires someone with a flexible and focused approach to minute taking, who can record information in an impartial way without imposing their own opinions. The role demands someone who can adapt to a varied and demanding workload and recognize the changing needs of the governance structure and the Corporate Secretariat...


  • Stockton-on-Tees, Stockton-on-Tees, United Kingdom Northern Powergrid Full time

    Job Title: Regulatory Reporting AnalystLocation: Dewsbury/CastlefordDirectorate: Energy SystemsAbout the Role:We are seeking a highly skilled Regulatory Reporting Analyst to join our Energy Systems Team. The successful candidate will support the timely production of regulatory reporting information, collaborate with colleagues to determine project...


  • Stockton-on-Tees, Stockton-on-Tees, United Kingdom Northern Powergrid Full time

    Job DescriptionWe are seeking a skilled Regulatory Reporting Analyst to join our Energy Systems Team at Northern Powergrid.The successful candidate will support the Lead Compliance Analyst in ensuring the provision of accurate and timely regulatory submissions to Ofgem.Key Responsibilities:Supporting the timely production of regulatory reporting...


  • Stockton-on-Tees, Stockton-on-Tees, United Kingdom PragmatIC Semiconductor Full time

    We are PragmatIC Semiconductor, a leading innovator in flexible electronics. We are seeking an experienced Material or Device Scientist with management experience to establish a new Device Physics team as part of our R&D group.The successful candidate will be responsible for leading material science and device physics programs for existing and upcoming...


  • Stockton-on-Tees, Stockton-on-Tees, United Kingdom NORTH YORKSHIRE COUNCIL Full time

    About the RoleWe are seeking an ambitious and forward-thinking individual to work as a regulatory lawyer within our successful legal service at North Yorkshire Council.The Legal Service is part of Legal and Democratic Services ('LDS') within the Chief Executive's Group. Our organization provides a range of services to the County of North Yorkshire, and the...

  • Compliance Officer

    4 weeks ago


    Stockton-on-Tees, Stockton-on-Tees, United Kingdom Reed Full time

    Reed Business Support is seeking a Compliance Officer to support a prestigious legal firm in Teesside. This role is integral to maintaining the firm's commitment to quality and excellence.Key Responsibilities:Plan and conduct monthly quality audits on fee earners to verify compliance with regulations and accreditation requirements.Perform risk assessments...

  • Maintenance Engineer

    4 weeks ago


    Stockton-on-Tees, Stockton-on-Tees, United Kingdom SABIC Full time

    Job SummarySABIC UK Petrochemicals Limited is seeking a skilled Maintenance Engineer to join our team at the Wilton International site. As a key member of the Maintenance team, you will be responsible for managing the timely and cost-effective specification, planning, scheduling, and oversight of maintenance tasks within your area.Key ResponsibilitiesLead...


  • Stockton-on-Tees, Stockton-on-Tees, United Kingdom Oxalis LogisticsLimited Full time

    About the RoleOxalis Logistics Limited is looking for an experienced Transport Operations Lead to join our team.You will be responsible for managing the operational aspects of our Fuels, Bitumen, and Gas operations, ensuring seamless delivery and high customer satisfaction.Package and BenefitsThis role comes with a competitive salary package, exceeding...