From Rieka Talent, we are looking for a Regulatory Affairs Specialist / Senior Regulatory Technician
We are seeking a highly motivated Regulatory Affairs Specialist / Senior Regulatory Technician to join our team. In this role, you will be responsible for ensuring that all medical aesthetic products (e.g., injectables, skincare devices, dermal fillers, energy-based devices) comply with applicable regulations and standards globally.
You will support product development, market access, labeling, promotional material review, and post-market regulatory requirements to maintain product approval and ensure company compliance.

Key Responsibilities:
- Regulatory Strategy & Submissions: Develop and execute regulatory strategies for new products, changes to existing products, and international registrations; prepare and submit regulatory dossiers; maintain licenses and approvals.
- Compliance: Ensure products meet integral regulatory requirements (MDR EU, FDA USA, Health Canada, TGA Australia, etc.); support audits; monitor regulatory trends and updates.
- Labeling and Marketing Review:



Review and approve product labeling, instructions for use, and promotional materials; collaborate with Medical Affairs, Marketing, and Legal teams to ensure compliant messaging.
- Post-Market Surveillance: Assist with adverse event reporting, field actions, and recalls; participate in complaint review and trending activities.
- Cross-Functional Collaboration: Work closely with R&D;, Medical Affairs, Manufacturing, Quality Assurance, Marketing, and Legal teams to integrate regulatory requirements from the design phase.

Requirements:
Requirements:
- 3+ years of experience in regulatory affairs within medical device, aesthetic, pharmaceutical, or skincare industries.
- Knowledge of MDR (EU), FDA (USA) regulations (21 CFR 820, 21 CFR 801, 510(k)), ISO 13485, and other relevant standards.
- Experience with Class II or III medical devices, particularly in aesthetics, dermatology, or plastic surgery.

📌 Regulatory Affairs Specialist (España)
🏢 RIEKA TALENT
📍 España