Regulatory Manager

Arevna; 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

Regulatory Affairs Manager - EMEA (Eastern Europe & CIS) - 12 Month Contract

Location: Remote (EMEA) - 5-10% Travel

Industry: Medical Devices

Level: Mid-Senior

The Role

Lead regulatory compliance, market access, and regulatory operations across North EMEA, with primary focus on Eastern Europe (EE) and CIS markets. Reporting to the Regulatory Director you will drive product registrations, distributor coordination, platform administration and promotional material reviews (Veeva).

Key Responsibilities

• Registrations & Lifecycle: Manage submissions, renewals, variations, and country-level pathways across EE/CIS.
• Documentation & Tenders: Coordinate Certificates of Free Sale (FSCs), legalizations, apostilles, and tender submissions.
• Regulatory Operations: Administer the FreshService ticketing platform (triage, SLA tracking, KPIs) and maintain eRIM records.
• Compliance & AdProm: Review labeling/artwork and run promotional compliance approvals in Veeva Vault.
• Post-Market Support: Support PMS, vigilance reporting, and CAPA resolution with Quality teams.

What You Need

• 5+ years in Medical Device Regulatory Affairs (EU/EMEA scope).
• Proven EE / CIS registration experience (EAEU regulations, Central Asia, Balkans).
• Working knowledge of MDR/IVDR, CE mark maintenance, and product lifecycle management.
• Experience with Veeva Vault (AdProm) and ticketing/workflow platforms (FreshService preferred).
• Strong grasp of FSCs, notarizations, and distributor-led market access.
• Languages: Fluent English; Russian or Polish strongly preferred.
• Education: BSc/MSc in Life Sciences, Biomedical Engineering, Pharmacy, or related field.