Regulatory Affairs Lead

3 weeks ago


Oxford Oxfordshire, United Kingdom Lenntech Search Full time

LennTech Search are working with an innovative software medical device company whom have a need for an experienced Regulatory Affairs Manager. Main Duties

  • Lead company regulatory submissions to the FDA.
  • Preparation of full 510(k) Q-Submissions.
  • Prepare and submit applications and reports to applicable regulatory agencies.
  • Respond to reviews and requests for information from regulatory bodies.
  • Ensure post-market surveillance is completed in line with applicable regulations.
  • Lead vigilance and regulatory authority reporting activities when required.
Education and Experience
  • Knowledge and/or experience in development of software (including AI) as a medical device.
  • Knowledge and/or experience in medical device regulatory requirements in the US, Canada and China are preferable..
  • Experience in a start-up or a fast-growing company.
#J-18808-Ljbffr

  • Oxford, Oxfordshire, United Kingdom Lenntech Search Full time

    LennTech Search are working with an innovative software medical device company whom have a need for an experienced Regulatory Affairs Manager. Main Duties Lead company regulatory submissions to the FDA. Preparation of full 510(k) Q-Submissions. Prepare and submit applications and reports to applicable regulatory agencies. Respond to reviews and...


  • Oxford, Oxfordshire, United Kingdom Lenntech Search Full time

    LennTech Search are working with an innovative software medical device company whom have a need for an experienced Regulatory Affairs Manager. Main Duties Lead company regulatory submissions to the FDA. Preparation of full 510(k) Q-Submissions. Prepare and submit applications and reports to applicable regulatory agencies. Respond to reviews and...


  • Oxford, United Kingdom Lenntech Search Full time

    LennTech Search are working with an innovative software medical device company whom have a need for an experienced Regulatory Affairs Manager. Main Duties Lead company regulatory submissions to the FDA. Preparation of full 510(k) Q-Submissions. Prepare and submit applications and reports to applicable regulatory agencies. Respond to reviews and...


  • Oxford, Oxfordshire, United Kingdom Lenntech Search Full time

    LennTech Search are working with an innovative software medical device company whom have a need for an experienced Regulatory Affairs Manager. Main Duties Lead company regulatory submissions to the FDA. Preparation of full 510(k) Q-Submissions. Prepare and submit applications and reports to applicable regulatory agencies. Respond to reviews and...


  • Oxford, Oxfordshire, United Kingdom Cpl Life Sciences Full time €60,000

    Senior Regulatory Affairs Specialist – Medical Devices & IVD’s Oxfordshire, UK – Office based Up to £60,000 + benefits Make sure to apply quickly in order to maximise your chances of being considered for an interview Read the complete job description below. This is an excellent opportunity to join a leading medical device manufacturing that is the...


  • Oxford, Oxfordshire, United Kingdom Perspectum Diagnostics Ltd. Full time

    Senior Regulatory Affairs Specialist About the role The Regulatory Affairs Specialist liaises with the Regulatory Affairs and Quality teams, R&D and Product Management to provide regulatory input into NPI Project Core teams and company operations. They assist in the preparation and submission of regulatory applications and registrations as assigned...


  • Oxfordshire, United Kingdom TEC PARTNERS LIMITED Full time

    I'm pleased to have partnered exclusively with a market leading and rapidly growing diagnostics company who are focused on developing and commercialising proprietary assays for infectious diseases. Their latest in-vitro diagnostic device has been approvedin over 50 countries where the product is used to diagnose one of the worlds largest cause of death of...


  • Oxford, United Kingdom Bond Williams Full time

    As Regulatory Affairs Specialist responsibilities include: - Collaborate closely with the Regulatory Affairs Manager to develop and maintain technical files and submissions for global regulators. - Utilise your regulatory expertise to support the development of regulatory strategies for product submissions. - Analyse routes to market and provide relevant...


  • Oxford, Oxfordshire, United Kingdom TEC PARTNERS LIMITED Full time

    I'm pleased to have partnered exclusively with a market leading and rapidly growing diagnostics company who are focused on developing and commercialising proprietary assays for infectious diseases. Their latest in-vitro diagnostic device has been approvedin over 50 countries where the product is used to diagnose one of the worlds largest cause of death of...


  • Oxford, United Kingdom Cpl Life Sciences Full time

    **Reference Number**: JO-2308-521008 Principal Regulatory Affairs Specialist **Rate**: £60,000 - 75,000 **Job Type**: Permanent **Location**: Oxford **Job Title**: Principal Regulatory Affairs Specialist **Job Type**: Permanent **Location**: Oxfordshire based **Salary**: £60,000 - £75,000 plus attractive benefits This is fantastic opportunity to...


  • Oxford, United Kingdom Mirada Medical Full time

    **About Mirada Medical...** Mirada Medical develops medical imaging and cancer treatment planning solutions that provide simple and accessible solutions to complex image analysis problems in the diagnosis and treatment of cancer and other diseases. Our solutions interoperate with other IT systems in the healthcare enterprise, such as EHRs and PACS,...


  • Oxford, Oxfordshire, United Kingdom GBXB Oxford Immunotec Limited Full time

    Regulatory Specialist (REMOTE or On-site) page is loaded Regulatory Specialist (REMOTE or On-site) Apply locations Oxford, UK - Oxford Immunotec time type Full time posted on Posted 3 Days Ago job requisition id JR-038611 Job Title Regulatory Specialist (REMOTE or On-site) Revvity is a developer and provider of end-to-end solutions designed to...


  • Oxford, United Kingdom Oxford Nanopore Technologies Full time

    **About Us** Oxford Nanopore's sequencing platform is the only technology that offers real-time analysis (for rapid insights), in fully scalable formats from pocket to population scale, that can analyse native DNA or RNA and sequence any length of fragment to achieve short to ultra-long read lengths. Our goal is to enable the analysis of any living thing,...


  • Oxford, United Kingdom Oxford Nanopore Technologies Full time

    About Us Oxford Nanopore Technologies is headquartered at the Oxford Science Park outside Oxford, UK, with satellite offices and commercial presence in many global locations across the US, APAC and Europe. Oxford Nanopore employs from multiple subject areas including nanopore science, molecular biology and applications, informatics, engineering, electronics,...


  • Oxford, United Kingdom Oxford Nanopore Technologies Full time

    About Us Oxford Nanopore Technologies is headquartered at the Oxford Science Park outside Oxford, UK, with satellite offices and commercial presence in many global locations across the US, APAC and Europe. Oxford Nanopore employs from multiple subject areas including nanopore science, molecular biology and applications, informatics, engineering, electronics,...


  • Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full time

    About UsOxford Nanopore's sequencing platform is the only technology that offers real-time analysis (for rapid insights), in fully scalable formats from pocket to population scale, that can analyse native DNA or RNA and sequence any length of fragment to achieve short to ultra-long read lengths.Our goal is to enable the analysis of any living thing, by...


  • Oxford, United Kingdom Perspectum Full time

    Senior Regulatory Affairs Specialist **About the role** The Regulatory Affairs Specialist liaises with the Regulatory Affairs and Quality teams, R&D and Product Management to provide regulatory input into NPI Project Core teams and company operations. They will assist in correspondence with review agencies, notified bodies, and trade associations on...


  • Oxford, United Kingdom Bond Williams Full time

    We are seeking a talented Regulatory Affairs Specialist to join our client's regulatory team in support of the expansion of their ISO 13485 diagnostics product pipeline. Reporting to the Regulatory Affairs Manager, you will play a crucial role in ensuring regulatory compliance and supporting the successful submission of our products to global regulatory...


  • Oxfordshire, United Kingdom Cpl Life Sciences Full time €60,000

    Senior Regulatory Affairs Specialist – Medical Devices & IVD’s Oxfordshire, UK – Office based Up to £60,000 + benefits This is an excellent opportunity to join a leading medical device manufacturing that is the world leader in Glucose Monitoring, their ranging product portfolio, develops and manufactures glucose monitoring systems for use in both...


  • Oxfordshire, United Kingdom Cpl Life Sciences Full time

    Senior Regulatory Affairs Specialist – Medical Devices & IVD’sOxfordshire, UK – Office based Up to £60,000 + benefits This is an excellent opportunity to join a leading medical device manufacturing that is the world leader in Glucose Monitoring, their ranging product portfolio, develops and manufactures glucose monitoring systems for use in both home...