An exciting opportunity has arisen for an experienced Senior RA Officer to join our team. This position can be home based from anywhere in the UK with regular travel to Newcastle. This is a professional position with responsibilities for elements of the site regulatory obligations. May include specialized responsibilities in adverse event reporting (MDR, Vigilance, HHE), registrations/submissions, regulatory intelligence, compliance, device listing, communications with regulatory bodies, recalls and field actions, advertising & promotion, regulatory support of new product development and device change processes. The Senior RA Officer / Specialist is experienced in multiple areas of medical device regulatory affairs and is capable of applying that experience and in-depth knowledge to work independently with minimal guidance from management. Serves as a resource for colleagues with less experience. May lead small projects with manageable risks and resource requirements. Ability to solve complex problems affecting site's regulatory obligations. Shares information and experience across LBS and Danaher sites; may serve as representative on taskforces, councils or improvement initiatives. In this role, you'll - Responsible for planning, organizing and conducting duties related to assigned areas of the site's regulatory obligations: May include one or more of the following areas: - Adverse events and patient safety (MDR, Vigilance, clinical trials) - Review and analyze product complaints, clinical reports and other data against established processes and procedures. - Make safety and filing decisions for routine matters. Collaborate with management and medical affairs for non-routine or serious events. - Compliance - Review and approve labeling, advertising and promotion for compliance to applicable regulations - Track the progress of new and updated regulations that impact the business (regulatory intelligence) - Implementation of new regulations: - Identify and implement new or updated regulations that are routine or do not have a major impact on the business - In conjunction with management, develop plans to implement regulations that have a significant impact on the business (e.g. IVDR, UDI, Companion and Complementary Diagnostics) - Participate and contribute to LBS or Danaher councils for regulatory intelligence and compliance - Submissions, registrations, device listings, site licenses - Work with global colleagues in support of product registrations and submissions. - Establish and maintain official site regulatory files according to government expectations and company procedures - Serve as site RA representative on new product development teams and change management initiatives - Establish and maintain device listings and licenses according to government requirements - Support the documentation of regulatory strategies - Utilize knowledge and experience to identify and solve problems within the regulatory area. - Serve as a resource and mentor to colleagues with less experience, including RA Officers. - Use Danaher Business System (DBS) tools on a regular basis to continually improve the RA function. - Establish and maintain strong relationships with internal and external stakeholders. - Maintain working knowledge of relevant regulations and requirements that affect the business. - Other duties as assigned by management. What you'll need to do the job - Bachelor's degree in science, medical or technical field and experience with increasing responsibility in medical device Regulatory Affairs - Graduate or advanced degree preferred - Experience in the IVD field preferred experience very beneficial - Must have requisite training or certification in medical device Regulatory Affairs through on-the-job training, seminars, training. Relevant certifications preferred. - Depending on assigned area: - Experience with regulatory submissions and registrations - Experience with regulatory affairs - Experience with regulatory compliance Interested? Join the Leica Bio Systems Team! Want to join our growing team that is helping our customers do incredible work? We look forward to your application! When you join us, you'll also be joining Danaher's global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.If you've ever wondered what's within you, there's no better time to find out.