Regulatory Affairs Manager
- Barcelona
- 50.000-55.000 € al año
- Permanente
- Tiempo completo
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 requisitesFormación : Licenciado: BiotecnologíaIdiomas : Inglés: C1Conocimientos : iso 13485Experiencia : 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 Englishwhy with Randstad?Because we have thousands of job offers in our portal.Because we work with the best companies offering you the best jobs.Because we assure you all the legal guarantees in your hiring.Because we guarantee a close follow-up after your incorporation, because we want you to be satisfied.Because we put at your disposal our advanced technology so that you can sign your contracts and access your labor documentation in a single click.Because we always count on you.Enroll in this offer, you will be part of the Randstad candidate database for future employment opportunities.Register now and find the job you are looking for!sustainable jobsRandstad's ambition is to be the world's most equitable and specialized talent company. We help talent and organizations unlock their true potential by seeking responsible opportunities that drive long-term economic sustainability, prioritizing the well-being of people and the planet.we are sustainable employmentOur conviction that all talent, regardless of their background, has equal opportunities for success is evident in our processes, in which we promote workplace equity through diverse and inclusive teams.commitment NetZeroWe strengthen our environmental commitment to achieve carbon neutrality by 2050 through the Science Based Targets initiative (SBTi).