Quality Assurance & Regulatory Affairs Specialist (Medical Software)

Full-time BARCELONA, SPAIN & REMOTE

Job Description 

We’re looking for a Quality Assurance & Regulatory Affairs (QARA) specialist (Medical Software) to join our team. As a QARA Specialist, you will be responsible for ensuring that all activities in our company including product development are performed following global quality standards and regulations. You will be reporting to the Director of Quality and Regulatory Affairs and working closely with other experts on our team (executives, engineers, researchers, human resources, operations, and the business team) to optimize our procedures and keep compliance and certificates. 

QMENTA is a multi-disciplinary science and engineering start-up. The company’s mission is to develop technologies to better understand the healthy and diseased brain. We are a fast-growing startup. In the last 10 years, we have expanded our business globally and served hospitals, research centers, and pharmaceutical companies in the US, Europe, and Asia-Pacific.

As we embark on this exciting new chapter of growth, we're thrilled to share that our company is well-funded, enabling us to explore innovative avenues and expand our impact. This significant support underscores our commitment to pushing boundaries and achieving new milestones, propelling us forward in this exciting journey.

Responsibilities

• Maintenance of our Quality Management System (QMS) and certificates according to ISO 13485, IEC 62304, FDA Title 21 CFR Part 11&820, Annex 11, EU GDPR, US HIPAA, ICH E6 (R3) GCP, and GxPs.
• Lead/coordinate the Management Review Meetings.
• Lead/coordinate the measurement and evaluation of the quality KPIs.
• Assist external audits and interact with authorities, consultants, or auditors.
• Prepare and lead the internal audits. 
• Responsible for the Documentation Control Process and Documentation Change Control Process.
• Coordinate corrective and preventive actions, and drive resolution of non-conformities. 
• Conduct internal training and lead the onboarding process required by regulations to ensure proper implementation of the QMS.
• Create, maintain, and update standard operating procedures (SOPs) (and policies) and lead the implementation of the procedures. 
• Assist the engineering and medical imaging research teams to ensure that products are developed and produced according to applicable regulations and standards.
• 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, and establishing local communication/channels for compliance on medical devices).
• Participate in the management of the complaints, establishing and maintaining complaint files, investigation, and trending. 
• Assist the different areas of the company in the evaluation of suppliers according to our supplier management process. 
• Assist in the implementation of data protection regulations (GDPR, HIPAA) and security standards (ISO 27001, etc.).

Required 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 leading internal audits. A certification is needed to support that experience. 
• Understanding of FDA and CE marking regulations. Especially, experience in 510(k) submissions.
• Experience in the software development life cycle in a regulated environment in the Healthcare sector (IEC 62304, IEC 82304).
• Strong written and oral communication skills. Advanced verbal and written English.
• Driven. Multitasking. Detail oriented. Proactive. 
• Familiarity with a multicultural team environment.
• Desire to work in a fast-paced growth-stage scaleup.

Desired qualifications (optional):

• 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 (R3) ). 
• Previous experience in external audits with CROs is a plus.
• Experience in the development of AI based-medical software is a plus. 
• Understanding of cloud security.

What we offer

• Competitive salary that reflects the skills and experience
• Flexible Work Environment Flexibility of working hours within our hybrid model 
• Inclusive and multicultural team Join a vibrant team that celebrates diversity, bringing together over 15 nationalities
• Health insurance coverage and flexible remuneration package
• Weekly delicious breakfast and team-building.
• Be a part of a dynamic and fast-growing organization where your contributions truly matter.

Only CVs in English will be taken into consideration.

If you want to be part of a positive impact in the biotech industry with an internationally highly qualified team, QMENTA is your place.

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.

Follow your career aspirations to QMENTA for diverse opportunities with a company that provides the growth and strength to build your future.

QMENTA is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.QMENTA.com, on Facebook at www.facebook.com/qmenta, and on Twitter.