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Regulatory Affairs Specialist

Regulatory Affairs Specialist

Advantage ConsultoresBarcelona, España
Hace más de 30 días
Descripción del trabajo

For our client, a leading B2B medical aesthetics group specializing in hyaluronic acid-based injectables and other solutions, we are seeking a Regulatory Affairs Specialist / Senior Regulatory Technician to be part of an expansion international project.

JOB PURPOSE

You will be responsible for ensuring that all medical aesthetic products comply with applicable regulations and standards globally. This role supports product development, market access, labelling, promotional material review, and postmarket regulatory requirements to maintain product approval and company compliance.

MAYOR ACCOUNTABILITIES

Regulatory Strategy & Submissions :

  • Develop and execute regulatory strategies for new product development, changes to existing products, and international registrations.
  • Prepare and submit regulatory dossiers and maintain licenses and approvals.
  • Develop or support a variety of clinical & regulatory documents including but not limited to clinical study protocols and amendments; clinical study reports; Informed consent forms; CDP, CEP / CER, SSCP, investigator brochures.

Compliance :

  • Ensure all products meet regulatory requirements,
  • Support internal and external audits.
  • Monitor and interpret regulatory requirements, trends, and changes that may impact on the business.

    • Labeling and Marketing Review :

  • Review and approve product labeling, instructions for use, and promotional materials for regulatory compliance.
  • Collaborate with Medical Affairs, Marketing, and Legal teams to ensure compliant messaging.
  • Prepare or support scientific manuscripts, abstracts, and posters for conferences and peer-reviewed journals.
  • Review technical summaries for internal and external stakeholders.

    • Post-Market Surveillance :

  • Assist in adverse event reporting, field actions, and recalls, when needed.
  • 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 ensure regulatory requirements are built into products from the design phase.

    • Education :

    Degree in Life Sciences (Master's preferred). Backgrounds in Medicine, Pharmacy, Biomedical Engineering, or related fields are ideal.

    Experience :

  • 3+ years in regulatory affairs within the medical device, pharmaceutical, skincare, or aesthetic industries.
  • Familiarity with Class II or III medical devices used in dermatology, aesthetics, or plastic surgery.
  • RAC (Regulatory Affairs Certification) is a plus.

    • Regulatory Knowledge :

  • Strong understanding of MDR (EU), FDA (USA) regulations (21 CFR 820, 21 CFR 801, 510(k) processes).
  • ISO 13485 and related standards.

    • Skills & Tools :

  • Proficiency with literature databases (PubMed, Embase) and reference tools (EndNote).
  • Exceptional written and verbal communication.
  • Detail-oriented and highly organized.
  • Able to manage multiple deadlines and projects simultaneously.
  • Proactive and solutions-driven, thrives in fast-paced environments.

    • Languages :

    Fluency in Spanish and English , both written and spoken, is required.

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    Regulatory Specialist • Barcelona, España