Regulatory Manager – Labeling Devices

This is a fully remote position, open to applicants in Spain.

📋 Description

• Offer guidance and insights on EU MDR, device labeling, and the global translation procedure.

• Ensure adherence to SmPC and labeling standards for pharmaceutical products within Europe.

• Review and quality check materials, produce documents, and meet submission deadlines for designated products.

• Evaluate competitor labeling strategies to maintain a competitive edge in the market.

• Stay informed about pertinent EU legislation and guidance.

• Supply information for artwork briefs related to EU production graphics.

• Deliver updates and forecasts to stakeholders during regular meetings.

• Lead or assist in project initiatives aimed at enhancing device labeling or ensuring compliance.

• Oversee device labeling within the RIM system.

⛳️ Requirements

• 5-7 years of experience in Regulatory, R&D, or a related field.

• A minimum of 3 years in Regulatory is preferred.

• Background in regulatory affairs concerning device and drug product labeling.

• Required experience in the European market.

• Strong understanding of the device labeling process.

• Excellent project management, problem-solving, strategic thinking, negotiation, interpersonal, and communication abilities.

• Proficient knowledge of EU regulatory guidelines related to device and drug product labeling.

• Must be capable of working autonomously and be adaptable to meetings across various time zones.

🏝️ Benefits

• Health insurance.

• Flexible work arrangements.