Regulatory Affairs Executive

Commercial teams support launches with sales, medical affairs and market access.

Position summary

Proizvodstvo Krastev is looking for a Regulatory Affairs Executive to join a small, steady team. Our Regulatory Affairs team supports drug products in clinical trials across the US, EU and Canada. Remote position. Most of the team is in Sofia, but nobody is required to come in.

Job duties

• Monitor new guidance documents and summarise changes for the business.
• Keep regulatory files and correspondence organised and inspection ready.
• File MDRs and support complaint and recall decisions with quality.
• Assess design and manufacturing changes for regulatory impact and document the rationale.
• Coordinate with international distributors on country registrations.
• Review labeling, IFUs and promotional materials for regulatory compliance and supported claims.
• Track submission timelines and commitments in Veeva Vault RIM or a similar system.
• Support EU MDR technical documentation and notified body reviews.

Minimum qualifications

• 3+ years of regulatory affairs experience in medical devices, pharma or biologics.
• Clear technical writing and careful editing.
• Bachelor's degree in a life science, engineering or pharmacy.
• Able to travel up to 10 percent.
• Knowledge of ISO 13485 and ISO 14971 for device roles.
• Comfortable managing several submissions and deadlines at once.

Nice to have

• Master's degree or PharmD.
• RAC certification from RAPS.

Schedule: Monday to Friday, standard business hours

€2,100 - €2,600/month

Why work with us

• Private medical care.
• Extra annual leave days.
• Meal vouchers.
• Training budget.
• Language courses.
• Annual bonus.
• Multisport card.

Start: Immediately.

Demo job created on 11jobs for testing and demonstrations. It is not an actual opening at Proizvodstvo Krastev EOOD.