Regulatory Device Specialist

Role: Regulatory Device Specialist responsible for preparing and submitting high-quality regulatory filings for medical devices globally, ensuring compliance with FDA and international authorities. Responsibilities include managing pre-market submissions (e.g., 510(k), EU MDR documentation), interpreting and communicating regulatory guidelines, reviewing post-market device changes, supporting compliance activities, and coordinating registration processes across multiple markets (e.g., US, EU, UK, Japan, China). They also oversee export documentation, assess new market entry strategies, review labeling and promotional materials, and support audits and inspections. Requirements: minimum of 3 years’ medical device regulatory experience, strong knowledge of cGMP, ISO 13485, FDA, and EU MDR requirements, and experience with international registration processes in at least three major markets. Preferred: background in aesthetics or related medical device fields, hands-on experience with regulatory dossiers (FDA 510(k), EU MDR Technical Documentation), and familiarity with Notified Body and global registry processes. Education: Bachelor’s degree. High-value specifics include focus on medical devices, global regulatory compliance, and experience with MDSAP, UKCA, and IMDRF standards. Work setup: remote with occasional travel.