Ofertas de empleo RA/QA

Acerca del puesto RA/QA

At Expansion People, a specialised recruitment agency, we are currently looking for a QA/RA Specialist to join an innovative company in the digital health sector.

Are you experienced in Quality Assurance and Regulatory Affairs within the medical device or health tech industry? Are you looking for a role where you can take ownership of compliance and contribute to international growth? Do you want to be part of a cutting-edge company that's transforming rehabilitation through technology?
This could be your next opportunity!

We are looking for a QA/RA Specialist, to join a growing and mission-driven team dedicated to improving healthcare through digital innovation.

What do we need from you?

  • Experience in Quality Assurance and/or Regulatory Affairs in the medical device or digital health sector.
  • Solid knowledge of ISO 13485:2016, ISO 14971:2019, and EU MDR 2017/745.
  • Educational background in Law, Pharmacy, Engineering, or Life Sciences.
  • A proactive, detail-oriented mindset with a passion for innovation and compliance.

What do we offer?

  • Strategic role within a high-impact health tech company.
  • Opportunity to lead quality systems and support global regulatory expansion.
  • Participation in multidisciplinary teams including R&D and commercial areas.
  • A dynamic, innovation-driven culture with international reach.

Your main responsibilities will include:

  • Leading and maintaining the Quality Management System (QMS) certified under ISO 13485.
  • Acting as the Regulatory Affairs representative within R&D and ensuring communication of key regulatory updates.
  • Ensuring compliance with the EU MDR 2017/745 and acting as PRRC (Person Responsible for Regulatory Compliance).
  • Managing product registrations in LATAM, the U.S., and other jurisdictions.
  • Assessing and ensuring data protection compliance for product-related information.
  • Reviewing client service contracts for regulatory compliance.
  • Overseeing promotional materials to ensure they meet regulatory standards.

If this role sounds like a fit for your background and interests, apply now or reach out directly wed love to hear from you.

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