Regulatory Affairs Specialist

Описание

Key Responsibilities: • Handle new registrations and registration changes for medical device certificates. • Follow up on the registration review and approval process, and handle official deficiency requests for supplementary information from regulatory authorities. • Liaise with local Russian technical and clinical testing laboratories, and follow up on the entire testing process • Prepare registration dossiers for Russian medical device registration • Submit registration documents through the Russian registration system (Roszdravnadzor portal) • Monitor changes in Russian medical device regulatory requirements, standards, and registration policies • Provide timely feedback on registration progress to supervisors and relevant departments Requirements: 1. Education (Russian Ministry of Education recognized): • Bachelor's or Master's degree in Pharmacy, Medicine, Chemistry, Biochemistry, or related fields 2. Experience: • Minimum 3 years of experience in IVD/medical device regulatory affairs •Proven experience in both new registrations and registration changes, with a track record of successfully obtaining registration certificates. • Hands-on experience with IVD, immunoassay, and clinical chemistry product portfolios, including diagnostic kits, analyzers, and reagents • Experience with Russian or EAEU registration 　 • Familiar with laboratory testing/evaluation Skills: • Good English proficiency and documentation skills • Strong knowledge of Roszdravnadzor regulations, EAEU rules, and ISO 13485 • Ability to manage multiple registration projects independently