Regulatory Affairs Specialist

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

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