QA/ra Manager

hace 3 meses

Barcelona, España The Blue Box Biomedical Solutions A tiempo completo

**About our company**

Women aged 20-49 cannot get breast cancer screened because existing solutions are unreliable. However, they want to, and 81% are ready to pay for it. At The Blue Box, we have built a radiation-free, pain-free, low-cost easy-to-operate device to detect breast cancer in urine with a sensitivity of 83%, accuracy of 79%, and specificity of 75%.

We are looking for a **QARA manager** that can assist us in setting up the QMS and writing the product Technical Documentation to obtain regulatory approval prior to market launch.

**Responsibilities**:

- To guarantee the existence and up-to-date status of the technical documentation and the EU declaration of product conformity, collaborating with cross-functional teams (R&D, manufacturing, clinical, marketing, etc.) to ensure regulatory compliance and timely product approvals or clearances.
- Lead and oversee the company's regulatory activities, including preparing and submitting technical documentation, CE marking, and interaction with notified bodies and competent authorities.
- Provide strategic guidance and ensure compliance with product development, manufacturing, and post-market surveillance processes in alignment with regulatory requirements.
- Conduct risk assessments and implement risk management strategies throughout the product lifecycle.
- Establish and maintain the company's Quality Management System (QMS) in compliance with relevant European regulations, ensuring adherence to ISO 13485 and other applicable standards.
- Manage and coordinate internal and external audits, ensuring compliance with regulatory and quality requirements. Develop and execute corrective and preventive action plans as necessary.

**Requirements, Qualifications and Experience**:

- Bachelor's degree in a scientific or engineering discipline (e.g., Biomedical Engineering, Biology, Chemistry) or related field. Advanced degree preferred.
- Proven experience (minimum 3 years) in a similar QARA role within the medical device industry, with a focus on Europe.
- Previous experience in QARA activities for similar medical devices, containing hardware and software units.
- In-depth knowledge of European medical device regulations (MDR and IVDR), ISO 13485, and other relevant standards.
- Demonstrated experience in successful interactions with notified bodies and competent authorities for regulatory submissions and audits.
- Fluent proficiency in English; knowledge of additional European languages is a plus.
- Experience with RA activities in the US and communications with the FDA is a plus.

**Yearly gross salary**: €34-35k, to be increased after the first 12 months, based on performance.

**About the team**
- This is an in-person job with 1 optional work-from-home day per week.
- The current team is integrated by 4 people: CEO, Tech Lead, Operations Lead, Data Lead. Meet the team here.
- Here are our social media platforms: linkedin, twitter, instagram.

Tipo de puesto: Jornada completa

Salario: 34.000,00€-35.000,00€ al año

Horario:

- De lunes a viernes

Requisito de idioma flexible:

- Español no requerido

Experiência:

- medical devices / in vitro diagnostics: 3 años (Obligatorio)

Idioma:

- Inglés (Obligatorio)

Ubicación del trabajo: Empleo presencial

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