Quality and Regulatory Affair (QARA) Manager

osteobionix; Santa Lucía de Tirajana; Presencial; EUR 40.000 - 70.000; Jornada completa

Descripción de la vacante

Una empresa innovadora en el diseño de dispositivos médicos busca un nuevo miembro para su equipo como Quality and Regulatory Affair (QARA) Manager. La posición está centrada en el desarrollo de implantes elásticos de próxima generación y requiere un PhD en áreas relacionadas junto con experiencia en procesos regulatorios. Se valorará un buen dominio del español y inglés, con posibilidad de reubicación en Gran Canaria.

Formación

• PhD requerido.
• Conocimiento de ISO 13485 y procesos MDR y FDA.
• Residencia o disposición para reubicarse en Gran Canaria.

Responsabilidades

• Apoyar la implementación de procesos de calidad y regulatorios.
• Documentar procesos necesarios para la obtención de autorizaciones de mercado.

Conocimientos

Conocimientos de procesos de calidad

Conocimientos de procesos regulatorios

Comando del español

Comando del inglés

Educación

PhD en farmacia, ingeniería biomédica o ingeniería mecánica

Descripción del empleo

At osteobionix, we design and manufacture innovative, clinically validated patient-specific implants and instruments for orthopedic, trauma, spine, thoracic, and CMF surgery. We have a long experience in 3D-printed porous metal and biopolymer scaffolds and we support surgeons in creating tailor-made, tissue-preserving solutions that align with the human body’s remarkable self-healing capabilities.

We are looking for a new team member willing to participate in the development ofthe next-generation elastic implants for chest-wall reconstruction and several other cutting-edge projects currently in our pipeline as a Quality and Regulatory Affair (QARA) Manager.

Our new team member will support the implementation and documentation of quality and regulatory processes required to obtain market clearance for implantable medical devices, helping to bring innovative technologies to patients.

Mandatory requirements:

• PhD in pharmacy, biomedical or mechanical engineering or related field.
• Knowledge and/or expertise in quality (ISO 13485) and regulatory (MDR and FDA) processes.
• Good command of spoken and written Spanish.
• Good command of spoken and written English.
• Residence or willingness to relocate to Gran Canaria, Spain.

Knowledge of medical device design and manufacturing processes (additive manufacturing, CNC machining) will be highly valued.

If this opportunity excites you and you are eager to join a great team on a sunny island while contributing to the development of highly innovative medical devices that improve patients’ lives, please do not apply here, but sendyour CV and a motivation letter (in Spanish or English) to Donato Monopoli ([e-mail]).

Please do not apply if you do not have all the mandatory requirements. We kindly ask recruitment agencies and headhunters not to submit applications, as they will not be reviewed.