About Methinks

Methinks vision is to provide universal and timely diagnosis for life-saving treatments worldwide. Our first focus is on stroke, the second cause of death and a major cause of disability in the world. Our product is an artificial intelligence medical imaging software capable of performing stroke triage and unlock stroke treatments potential from non-contrast CTs.
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Methinks is a VC backed digital health start-up that recently won the prestigious EIC Accelerator of the European Commission and has obtained two gold medals in the RSNA Kaggle competitions. The recent funding of the company will allow us to grow rapidly and we are looking for exceptional and passionate individuals to help us face these challenges and build together a unique company.

Job Summary

Coordination of the regulatory, quality and information security activities within the company to ensure compliance with standards and regulations for medical devices.

The role of Senior QA/RA Specialist is an integral part of any organization. This contributor applies extensive organizational skills and knowledge both as an individual and as part of a team, to assure that documents meet the needs of the organization as well as meeting regulatory requirements (in terms of standards and regulations) and quality assurance requirements (in terms of good engineering).

The Senior QA/RA Specialist is expected to provide significant guidance as well as hands on support in the development of new documents, procedures, and changes to existing procedures, processes, plans, and other quality system documentation.

Duties and Responsibilities

Responsibilities for the Regulatory activities:
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- Conformity of the product device to the Medical Device Regulation (MDR 2017/745) and Quality Management System (QMS);
- Conformity of the medical devices to the FDA regulations applicable and preparation of the documentation for FDA submissions;
- Conformity of the Technical Documentation and EU Declaration of Conformity;
- Compliance with Post-Market Surveillance (PMS) following Article 10(10) of MDR 2017/745;
- Compliance with the vigilance reporting obligations (Article 87 to 91 of MDR 2017/745);
- For investigational devices, issuance of a signed statement (Annex XV Chapter II Section 4.1 MDR 2017/745).
Responsibilities for the Quality Management System activities:

- Responsible for the conformity of the product and Quality Management System (QMS) to the US FDA 21 CFR Part 820 and requirements related to the product Code: QAS (Radiological Computed-Assisted Triage and Notification Software) within the 892.2080 regulation number;
- Actively participate in the maintenance and continuous improvement of the Quality System.
- Responsible for the conformity of the product follow the ISO 13485, ISO 14971, IEC 62304, CSV and MDCGs.

Skills and Qualifications

Minimum of two years of experience in Regulatory Affairs or Quality Management Systems (QMS) specific to the medical device industry.
Understand basic QA/RA principles:

- Must be aware of 21 CFR Part 820;
- Must be aware of ISO 13485 Quality Management System, Medical Device;
- Must be aware of MDR 2017/745;
- Must be aware of IEC 62304 Medical Devices - Software Life Cycle Process;
- Must be aware of ISO 27001 Sistemas de Gestión de Seguridad de la Información;
- Must be aware of ISO 14971 Risk Management for Medical Devices;
- Must be aware of 21 CFR Part 11;
- Must be aware of Regulation (EU) 2016/679;
- Must be aware of Health Insurance Portability and Accountability Act of 1996 - HIPAA;
- Must be aware of FDA guidelines;
- Must be aware of Computer System Validation - CSV (EU) and Computer Software Assurance - CSA (US).
A diploma, certificate or evidence of formal qualification awarded on completion of a university degree or of other recognized equivalent in law, medicine, pharmacy, engineering or other scientific discipline;
Full competence in Spanish and English;

What can we offer

An opportunity to shape the regulatory strategy of an award-winning Digital Health Start-Up.
Be part of a solid experienced team, passionate about their work and capable to bring cutting-edge technology to market.
Chance to grow alongside extraordinary individuals at the company growth pace.
Combine remote work with working together in our great offices in front of the Port Vell, at Pier01 Barcelona Tech City.
Competitive compensation package.

You’re one step closer  to being part of the team.

About Methinks

Job Summary

Equal
Employee
Opportunity

Duties and Responsibilities

Skills and Qualifications

What can we offer

Fill in your information here

You’re one step closer to being part of the team.

About Methinks

Job Summary

EqualEmployeeOpportunity

Duties and Responsibilities

Skills and Qualifications

What can we offer

Fill in your information here

You’re one step closer  to being part of the team.

Equal
Employee
Opportunity