Quality and Regulatory associate Junior (SaMD)

Mediktor is looking for a QA/RA specialist!

If you are passionate about applying the regulation to cutting edge technology and you would like to discover the Software Medical Device regulation, we are looking for you!

The Team:

As a member of the Quality Department, you will collaborate closely with all teams and departments at Mediktor, supporting them in meeting regulatory and quality requirements. You will play a key role in the implementation and maintenance of an integrated management system, ensuring effective compliance with the AI Act, MDR, and accessibility standards across the organization.

Responsibilities:

• Manage and update Integrated Management System documentation to ensure organization-wide compliance.
• Participate in internal and external audits to verify adherence to quality standards.
• Partner with teams to integrate and uphold quality requirements across departments.
• Validation & Risk: Execute and oversee the validation systems and the risk management framework to mitigate operational gaps.
• Direct the CAPA and Change Order processes to drive continuous improvement.
• Execute supplier evaluations to ensure high-quality procurement standards.
• Strategic Support: Perform additional duties and key projects as assigned.

Requirements:

• Life Science Degree studies
• Fluent in English and Spanish
• Strong attention to detail
• Excellent communication and interpersonal skills, and a desire to learn and grow professionally
• At least 1 year of experience in a QA/RA role (including trainee position)

We Are Looking For Someone

• With a curious mind to be up to date of what is going on in the company and the trends and innovations of the sector.

What you will find working with Mediktor:

An exciting scale-up company sharing good vibes & excellent multicultural and team working environment