Regulatory Affairs Manageren Barcelona.
detalle oferta
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Paula Labalsa I Ibarz
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To lead and oversee all regulatory activities related to the development, approval,
and commercialization of the company¿s in vitro medical devices. The Regulatory
Affairs Manager ensures implementation of Quality Management System,
compliance with applicable regulations (such as IVDR, ISO 13485, and FDA
guidance), manages regulatory submissions and audits, and contributes to the
overall strategy to bring innovative products to market efficiently and compliantly.
your functions
- Define and implement regulatory strategies for new and existing products.
- Ensure compliance with applicable regulations (IVDR, MDR, ISO 13485, FDA, etc.).
- Prepare and maintain regulatory documentation and technical files.
- Accountable for the implementation of the Quality Management System
- Acts as a Person Responsible for Regulatory Compliance
- Acts as a Vigilance Manager
- Lead communication with regulatory authorities and notified bodies.
- Monitor regulatory changes and ensure timely adaptation of internal processes.
- Performs internal reviews to confirm compliance with QMS and regulatory standards
- Support internal teams (R&D, Clinical) to ensure compliance across the product lifecycle.
- Coordinate and provide guidance during audits, inspections, and certification processes.
- Train and mentor team members on regulatory best practices.
position requisites
-
Formación
: Licenciado: Biotecnología -
Idiomas
: Inglés: C1 -
Conocimientos
: iso 13485 -
Experiencia
: 6 años
- 4¿6 years of experience in regulatory affairs for medical devices or diagnostics.
- Proven experience with IVDR and/or FDA regulatory pathways.
- Proven experience of Notified Body submissions and audits for CE Mark or ISO 13485
- Strong knowledge of EU and US regulatory frameworks (IVDR, MDR, FDA, ISO standards).
- Excellent writing and documentation skills.
- Project management and cross-functional coordination capabilities.
- Analytical and strategic thinking.
- Excellent verbal and written communication in English
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Because we guarantee a close follow-up after your incorporation, because we want you to be satisfied.
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Because we always count on you.
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