Regulatory Affairs Manager (Medtech)

TL;DR

Regulatory Affairs Manager (Medtech): Managing the post-approval life-cycle of global legacy products with an accent on regulatory compliance and international submission strategies. Focus on coordinating variation packages across EU and global markets and ensuring alignment with Health Authority requirements.

Location: Sant Feliu de Llobregat, Spain

Company

A global pharmaceutical company specializing in medical dermatology, recognized as a Top Employer in Spain and Germany.

What you will do

• Execute regulatory strategies and submission plans for post-approval changes and responses to Health Authority queries.
• Prepare and review variation packages (labeling, administrative, clinical, and non-clinical) for assigned products.
• Monitor regulatory procedures and maintain up-to-date registration databases and annual renewal schedules.
• Supervise regulatory activities performed by consultants, CROs, local agents, and strategic partners.
• Develop and maintain policies and procedures governing regulatory operations with market companies.
• Provide regulatory expertise in cross-functional projects aligned with business strategy.

Requirements

• Bachelor’s Degree in Life Sciences (advanced degree preferred).
• Minimum 5 years of experience in Regulatory Affairs within international regions (EU, Turkey, Russia, CIS, MEA, LATAM, APAC).
• Strong knowledge of post-approval regulatory procedures, particularly in EU markets.
• Hands-on experience managing EU registration procedures (CP/DCP/MRP) and dossier preparation.
• English: Fluent proficiency (C1) required.
• Location: Must be based in Sant Feliu de Llobregat, Spain.

Nice to have

• Excellent organizational and project management skills.
• Proven ability to build relationships in a global team environment.
• Proficiency in regulatory systems and document management tools.

Culture & Benefits

• Environment focused on independent thinking, ownership, and impactful work.
• Recognized as a Top Employer in Spain since 2008 and Germany since 2025.
• Commitment to professional growth and internal mobility.