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
