Barcelona/Spain & Remote
As a Quality Assurance & Regulatory Affairs (QARA) specialist, you will be part of the QARA team reporting directly to the QARA Director. The QARA specialist will be responsible for ensuring that all activities related to our products from its development to its launch into the market, including its maintenance and monitoring, are performed with the highest quality and security by following standards and regulations. The QARA specialist will also be responsible for ensuring that our products meet all requirements needed for being used in clinical trials, and all market medical device regulations. You will collaborate internally with other experts on our team (executives, engineers, researchers and the business team) to optimize our procedures and maintain certificates.
- Prepare documentation for FDA, CE mark or any other regulatory submissions.
- Manage and establish / maintain compliance with health authorities (including company registration, new product submissions, establishing local communication/channels for compliance on medical devices).
- Maintenance of our quality management system and certificates according to ISO 13485, IEC 62304, FDA Title 21 CFR Part 11&820, Annex 11, EU GDPR, US HIPAA and GxPs.
- Assist internal / external audits and interact with authorities, consultants or auditors.
- Coordinate corrective and preventive actions, and drive resolution of non-conformities.
- Participate in the management of the complaints, establishing and maintaining complaint files, investigation, and trending.
- Assist the engineering and medical imaging research teams to ensure that products are developed and produced according to applicable regulations and standards.
- Conduct internal training required by regulations to ensure proper implementation of the quality standards.
- Responsible for the Documentation Control Process and Documentation Change Control Process.
- Maintain and improve standard operating procedures and policies.
Desired Skills and Experience
- At least 5 years of professional experience as a QARA specialist, ideally in medical software.
- Working knowledge of Quality Management System (ISO 13485, FDA Title 21 CFR Part 820).
- Experience in Data Protection Regulations (EU GDPR, US HIPAA).
- Understanding of FDA regulations. Especially experience in 510(k) submissions.
- Experience in leading internal audits.
- Strong written and oral communication skills. Advanced verbal and written English.
- Driven. Multitasking. Detail oriented. Proactive.
Desired Qualifications (optional)
- Experience in CE mark.
- Proficiency in Confluence, Jira and G-drive.
- Experience in the requirements needed for the execution of Clinical Trials (FDA Title 21 CFR Part 11, Annex 11, GxPs, ICH: E6 (R2) ).
- Previous experience in external audits with CROs is a plus.
- Experience in the software development life cycle in a regulated environment in the Healthcare sector (IEC 62304).
- Experience in the development of AI based-medical software is a plus.
- Understanding of cloud security.
- Familiarity with a multicultural team environment.
- Desire to work in a fast-paced growth-stage scaleup.
QMENTA was founded to empower the breakthroughs that will ultimately make brain diseases a thing of the past. We deliver on our vision by helping researchers, clinical trial leaders, and innovators do their work better and faster by serving as the indispensable hub for data, tools, and expertise that accelerates the understanding, diagnosis and treatment of brain diseases. How? We bring to market a powerful package of sophisticated technologies integrated into a single software solution that easily fuses big brain data with AI analytics.
At QMENTA, we strive on solving hard problems with creative solutions, and have fun during the process. In everything we do, we’re guided by our ABCDE’s core values:
- Positiveness: We face challenges with a positive attitude.
- Encourage: We work hard and share your enthusiasm.
- Amplify: We amplify our capabilities and multiply results.
- Brains before brawn: We are resourceful and innovative.
- Proactive: We generate constructive change both personal and professional.
- Pride: We take pride in our work and recognize it.
- Ambition: We tackle important and meaningful problems.
- Impact: We are making a difference in the world.
- Excellence: We set the bar high.
- Fast delivery: We are nimble and efficient.
- Quality: We understand our clients and deliver the highest quality product.
- Accountability: We are pragmatic and meet our commitments.
- Privacy and Security: We design our systems to protect data following global industry standards.
- Expertise: We have the knowledge and skills to solve your problems.
- Trust: We are honest, ethical and our word is our bond.
Only CVs in English will be taken into consideration.
We are an exciting and rapidly growing business where everyone works hard towards a common goal of exceeding customer expectations. We are looking for the right candidate to join us on our journey.