Regulatory Affairs Specialist

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 global 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:

• 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.
• RAC (Regulatory Affairs Certification) is a plus.
• Proficiency in literature databases (PubMed, Embase) and reference management tools (EndNote).
• Strong written and verbal communication skills in English and Spanish.
• Detail-oriented, organized, and able to manage multiple projects simultaneously.
• Proactive, solution-oriented, and comfortable in a fast-paced environment.
• Degree in Life Sciences (Pharmacy, Biomedical Engineering, Biotechnology, Biology or related field). A Master’s degree in Regulatory Affairs or similar is a plus.

Why Join Us:

By joining our team through Rieka Talent, you will play a key role in ensuring global regulatory compliance for cutting-edge medical aesthetic products, supporting product innovation, and helping bring safe, effective products to market faster.

Salary range

• Regulatory Affairs Specialist: 33.000 – 37.000 €

• Senior Regulatory Affairs Technician: 42.000 – 46.000 €