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Nuria GimenezNG

Nuria Gimenez

Health Regulatory and Marketing Consultant

€500/day
Madrid, ES
8-15 years

Average response time: 1 hour

Freelancer profile translated to English.
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About Nuria

I am a business consultant specializing in the healthcare, biotechnology, and technology sectors, with comprehensive experience in regulation, strategy, quality, communication, and brand development. I support companies, laboratories, clinics, and healthtech startups across three key areas: regulatory and quality compliance (ISO 13485 and CE-IVDR), strategic development and business planning, and corporate identity design, visual communication, and digital presence.

I offer services for evaluating and reviewing technical documentation, identifying regulatory and technical gaps, classifying medical devices and software, and implementing quality management systems according to ISO 13485. My approach is to simplify regulatory complexity and transform compliance into a strategic growth tool.

Furthermore, I develop business plans, marketing strategies, and positioning for companies looking to scale or redefine their model. I advise on pricing, sales channels, partnerships, and international development, helping to transform innovation into a competitive advantage.

As a startup mentor, I offer coaching programs focused on accelerating growth, optimizing timelines, defining objectives, and designing efficient processes. I support founding teams in leadership, change management, and fundraising.

I also design visual identities, strategic presentations, corporate materials, and professional SEO-optimized websites, unifying brand image with business strategy.

My offering integrates technical precision, strategic vision, and creativity, helping companies meet demanding regulations without losing competitiveness, while building a solid, differentiated, and coherent brand.
  • Spanish

    Native or bilingual

  • English

    Fluent

Remote only
Primarily works remotely

Experience

  • AI innovare group sl
    ISO 13485 and CE-IVDR Consulting for Medical Software
    HEALTH AND WELLNESS
    January 2022 - October 2025 (3 years and 9 months)
    I support companies in the healthcare sector in implementing ISO 13485 quality systems and preparing for CE-IVDR marking for medical software (SaMD).

    Services I offer:

    Comprehensive evaluation of technical documentation in accordance with Regulation (EU) 2017/746.

    Identification of regulatory and technical gaps, with a detailed plan of corrective actions and points to add to meet IVDR requirements.

    Classification of products and technical documentation (Annexes II and III of the IVDR).

    Implementation and optimization of the ISO 13485 Quality Management System.

    Preparation of UDI documentation, DoC, risk management, and change control.

    Continuous advice on regulatory compliance and liaison with notified bodies or competent authorities (AEMPS).

    Experience: development and evaluation of artificial intelligence software certified under CE-IVDR, including technical review, modular design, and documentation for audits.

    Languages: Spanish / English
    Regulatory Consulting Business Development Strategy CE IVDR ISO 13485 Healthcare Consulting
  • AI innovare group sl
    Marketing and Business Development
    January 2022 - October 2025 (3 years and 9 months)
    I help companies in the health, biotechnology, and technology sectors define their value proposition, design their sales funnel, and create sustainable growth strategies.

    Services:

    Digital marketing plan (SEO/SEM, LinkedIn, B2B/B2C campaigns)

    Brand positioning and communication

    Definition of pricing, commissions, and business model

    Presentations for investors and partner acquisition
  • AI innovare group sl
    Professional Presentation Design and Corporate Branding
    January 2022 - October 2025 (3 years and 9 months)
    I design high-impact visual materials: presentations, catalogs, logos, and corporate materials, adapted to each brand's style.

    Services:

    PowerPoints for investors or scientific talks

    Logo design and brand guidelines

    Sales dossiers and product sheets

    Creatives for social media and packaging

    Keywords: graphic design, PowerPoint, branding, visual identity, logo, Canva, Adobe Illustrator

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Education

  • Biotechnology
    Polytechnic University of Valencia
    2022

Skill set

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