Officer Job - Medical Devices Regulatory Affairs - Competitive - Newcastle, North England
Your new company
Your new company are passionate about advancing Cancer Diagnostics and improving people's lives in the process. Their recent research enables clinicians to efficiently provide patients a highly confident diagnosis rapidly after biopsy. They are a global leader in workflow solutions and automation, focusing on workflow integration, owning their own workflow from biopsy to diagnosis. Improving lives is at the heart of their culture, and if you share this vision, they provide a place for you to learn and grow. This is a goal they are striving towards, and will guide their future strategies. Ultimately they aim to decrease the time it takes from biopsy to patient diagnosis.
Your new role
As Regulatory Officer you will hold responsibilities for supporting tasks associated with the site regulatory obligations. The Regulatory Officer will follow existing policies, procedures and work instructions to plan and conduct tasks, and receive instruction and guidance from manager(s) or Sr. RA Officer/Specialist(s). Growing in experience, the RA Officer/Specialist will work more independently and apply experience to more complex tasks and problems.
As Regulatory Officer you will be expected to conduct tasks that support one or more areas of the site regulatory responsibilities. Adverse events and patient safety (MDR, Vigilance, clinical trials) will be a key part of the job, including the review and analysis of product complaints, clinical reports and other data against established processes and procedures. You will be responsible for supporting and organising safety and filing decisions for in collaboration with Sr. RA Officer(s), RA management. Compliance will be essential, as will the support, organisation of the review and approval of labelling, advertising and promotion for compliance to applicable regulations You will support Sr. RA Officer(s), RA management in the implementation of new regulations. Submissions, registrations, device listings and site licenses will all be important.
You will have the responsibility of working with global colleagues in support of product registrations and submissions, and establishing and maintaining official site regulatory files according to government expectations and company procedures. The Regulatory Officer will serve as site RA representative on new product development teams and change management initiatives, as well as establishing and maintaining device listings and licenses according to government requirements, and supporting the documentation of regulatory strategies.
You will utilise knowledge and experience to identify and solve problems within the regulatory area and use Danaher Business System (DBS) tools on a regular basis to continually improve the RA function. Whilst serving as a resource to support senior staff including Senior RA Officer/Specialist(s) and establishing and maintaining strong relationships with RA colleagues and wider QRA team. Alongside these responsibilities you will maintain working knowledge of relevant regulations and requirements that affect the business, with other duties as assigned by management.
What you'll need to succeed
A Bachelor's degree in science, medical or technical field and experience in medical device Regulatory Affairs, a Graduate or advanced degree would be preferred. Experience in the IVD field preferred experience very beneficial and you must have requisite training or certification in medical device Regulatory Affairs through on-the-job training, seminars, training. Relevant certifications would be preferred, as would experience with regulatory submissions and registrations, regulatory affairs and regulatory compliance.
What you'll get in return
You will be offered a highly competitive salary, as well as an excellent range of company benefits.
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.