Regulatory Affairs Specialist

Job description

Location: - U.S. based role working from home - Limited international travel to Europe as required - Regular collaboration with global teams across the U.S., Europe, and Canada About this Role (Responsibilities): - This is a remote role with some travel required to global offices. - Actively involved with the Laboratory Operations team, QA/RA team, Commercial, legal and R&D teams to generate regulatory plans and strategies for digital pathology products and services including with AI technology in North America. - Maintain and implement the compliance plans to ensure continued compliance for our services and products in North America. - Make submissions for regulatory and accreditation applications for new products/ services to project timelines to the applicable regulatory bodies including state agencies such as US (FDA, CMS-CLIA-LDT), Canada (CAP, SCC). - Develop, compile and review the technical documentation required for regulatory submissions: USA, Canada. Support Regulatory Affairs team with UK, EU, Rest of World (ROW) submissions as needed for digital pathology solutions and services. - Lead communications and engagement with Notified Bodies, Competent Authorities, and inter...