Intern - Regulatory Affairs
Core
Support regulatory submissions for Next Generation Sequencing (NGS) medical devices and clinical trials in the European Union.
Role type
Regulatory Affairs Intern
Builds
Regulatory submissions and post-market surveillance data for NGS products
Domain
Healthcare diagnostics / Medical Devices / Genetics
Deliverable
client delivery
Required skills
Literature review, scientific database research, genetic variant research, regulatory requirement analysis, compliance adherence
Preferred skills
NGS technology familiarity, US/global medical device regulatory knowledge, attention to detail, independent work capability
Technologies
Scientific databases, NGS technology
Responsibilities
Review scientific literature protocols and confirm data sources; Execute literature reviews to identify NGS market information and competing technologies; Research genetic variants for cancer therapies; Research EU ethical committee and competent authority submission requirements; Participate in regulatory body submissions and post-market surveillance reporting
Seniority
Intern