Remote Regulatory Manager, EMEA (EE/CIS) - 12 Month Contract

Arevna Limited; United States; Remote; USD 110,000 - 150,000; Full time

Job summary

Arevna Limited is seeking a Regulatory Affairs Manager for EMEA, focusing on Eastern Europe and CIS markets. This remote (EMEA) role involves leading regulatory compliance, market access, and regulatory operations across North EMEA with 5–10% travel.

You will drive registrations, manage distributor coordination, and oversee platform administration including Veeva Vault for AdProm and go‑to‑market approvals. Strong MDR/IVDR knowledge and experience with EE/CIS registrations are required.

Qualifications

• 5+ years in Medical Device Regulatory Affairs (EU/EMEA scope).
• Experience with EE/CIS registrations (EAEU regs, Central Asia, Balkans).
• Working knowledge of MDR/IVDR, CE mark maintenance, and product lifecycle.

Responsibilities

• Lead regulatory compliance, market access, and regulatory operations across North EMEA with focus on EE/CIS.
• Drive product registrations, distributor coordination, platform admin and promotional material reviews in Veeva Vault.
• Manage submissions, renewals, variations, and country-level pathways across EE/CIS.
• Coordinate FSCs, legalizations, apostilles, and tender submissions.
• Administer FreshService ticketing platform and maintain eRIM records.
• Review labeling/artwork and regulatory compliance approvals in AdProm.

Skills

Regulatory experience

EE/ CIS registration

MDR/IVDR knowledge

Veeva Vault (AdProm)

FreshService experience

Documentation management

Quality/regulatory liaison

Languages: English

Education

BSc/MSc in Life Sciences

Biomedical Engineering, Pharmacy

Tools

Veeva Vault

FreshService

Job description

Arevna Limited is seeking a Regulatory Affairs Manager for EMEA, focusing on Eastern Europe and CIS markets. This remote (EMEA) role involves leading regulatory compliance, market access, and regulatory operations across North EMEA with 5–10% travel.

You will drive registrations, manage distributor coordination, and oversee platform administration including Veeva Vault for AdProm and go‑to‑market approvals. Strong MDR/IVDR knowledge and experience with EE/CIS registrations are required.