, and are looking for a Regulatory Affairs Manager, responsible for on-market regulatory activities associated with US FDA, EU Notified Body..., team setting. Job Summary The primary responsibility of the Manager of Regulatory Affairs is to submit global...
. Job Description We are seeking a highly motivated and experienced Regulatory Specialist to join our Regulatory Affairs team. The ideal candidate... and other regulatory body requirements. Responsibilities · Prepare and submit 510(k) applications for IVD products to ensure timely...
address some of the world’s greatest healthcare challenges. This Director will be a highly experienced manager... Practice (GCP) guidelines and relevant regulatory standards. Manage clinical trial budgets, timelines, and resources...
sales plans to achieve revenue targets Partners with segment and regional marketing, medical affairs and other teams... in the LDT or IVD markets Strong knowledge of oncology molecular diagnostics testing market and applications Knowledge...
, you will do more and become more than you ever thought possible. Oncology WGS/MRD Staff Product Manager, Oncology Summary: Responsible for managing... affairs and other teams to define and obtain alignment on strategies and new program proposals Product Lifecycle Management...
strategy together with key stakeholder departments (e.g. R&D, Regulatory Affairs, Marketing, Scientific Affairs). Leads... to support corporate goals and objectives Excellent working knowledge of GCP, clinical affairs, and regulatory affairs The...
and process validation activities. As Product Transfer & Packaging Design Manager, this position is responsible of managing the... processes, efficiency, productivity, meeting all the quality and regulatory requirements to better serve our internal customers...
Job Description: We are hiring in our Diagnostics division here in San Diego! The Clinical Affairs department..., collection and tracking of regulatory documents for site compliance and audit readiness. Assist Study Lead with subject...