Regulatory Manager
Job in
Boise, Ada County, Idaho, 83701, USA
Listed on 2026-11-01
Listing for:
Arevna
Full Time
position Listed on 2026-11-01
Job specializations:
-
Pharmaceutical
Regulatory Compliance Specialist, Healthcare Compliance
Job Description & How to Apply Below
Regulatory Affairs Manager - EMEA (Eastern Europe & CIS) - 12 Month Contract
Location: Remote (EMEA) - 5-10% Travel
Industry: Medical Devices
Level: Mid-Senior
The RoleLead 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 Fresh Service 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.
- 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 (Fresh Service 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.
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