Regulatory Affairs Specialist
If you’re passionate about regulatory affairs and want to make a difference in women’s health, we’d love to meet you!
Actual Talent is the talent acquisition consultancy that offers Executive Search, RPO and Talent Solutions.
Our purpose is to drive the growth and fulfillment of individuals and organizations. We facilitate individuals in finding inspiring opportunities and help organizations discover professionals who will take them to the next level. We do this through talent acquisition and development solutions that focus on people, diversity and inclusion, innovation, and cutting-edge technology.
About the client
Our client is a leading Spanish pharmaceutical laboratory with a strong international footprint, recognized for its commitment to innovation in the women’s health sector. They specialize in the research and development of natural, scientifically-backed solutions designed to improve well-being across all stages of a woman's life—from fertility and pregnancy to menopause. By joining their team, you will be part of a purpose-driven organization that blends pharmaceutical rigor with a passion for high-quality, specialized healthcare.
Your Mission
In this role, you will support regulatory activities for food supplements and medical devices specifically designed for women’s health (fertility, pregnancy, menopause, etc.) across Europe and international markets. You will also have the opportunity to support pharmaceutical-related regulatory tasks based on business needs.
Key Responsibilities
Product Registration & Market Access:
- Support notifications and registrations of food supplements and medical devices in the EU and ROW markets.
- Compile documentation for product launches, renewals, and lifecycle management.
- Track submission timelines and approvals globally.
Ingredients & Formulation Compliance:
- Assess formulations (vitamins, minerals, botanicals, probiotics) for compliance with authorized lists and country-specific restrictions.
- Manage documentation regarding ingredient safety and "novel food" status.
Labeling & Claims:
- Review packaging and marketing materials to ensure compliance with health regulations.
- Assess nutrition and health claims (hormonal balance, bone health, etc.) to align them with brand strategy and legal requirements.
Medical Devices Support:
- Assist in maintaining technical documentation and product variations under supervision.
What we’re looking for
Experience: Minimum 2 years in EU medical devices and food supplements regulations.
Knowledge: Deep understanding of regulatory requirements and ability to interpret technical guidance documents.
Skills: Experience working with external partners (consultants, distributors), high attention to detail, and ability to manage multiple timelines.
Languages: Fluency in Spanish and English (written and spoken) is essential. Other languages are a plus.
What we offer
Stability: Permanent contract in a purpose-driven company.
Growth: International exposure and high-impact projects in the women’s health sector.
Flexibility: * Flexible start time (between 8:30 and 9:30 a.m.).
Remote work on Fridays (9:00 a.m. to 2:00 p.m.).
Benefits: Private health insurance and an excellent working environment.
- Department
- Pharma & Medical Devices & Chemicals
- Role
- Regulatory affairs
- Locations
- Barcelona
- Remote status
- Hybrid
- Employment type
- Full-time