Compliance Engineer

Barcelona, Cataluña, Spain

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

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 The Compliance Engineer is a vital role within our organization, bridging the regulatory, product, and tech departments to ensure adherence to the highest standards and regulations in the medical device industry. This position requires a technical, hands-on approach, coupled with an in-depth understanding of both regulatory compliance and product development.

In this key role, the Compliance Engineer will ensure that our technology adheres to the regulatory standards. They will orchestrate the identification, implementation and validation of the technology necessary to meet and surpass industry requirements. They will also manage the compliance activities associated with the technology, including the documentation of our technical processes and the training within the company to ensure the best security practices.

As a central figure in aligning our innovative efforts with industry regulations, the Compliance Engineer will ensure our operations are not only technologically advanced but also fully compliant. This dynamic position demands a proactive and technically proficient individual who can adeptly navigate the complexities of compliance in a fast-paced environment.

We proudly pursue a diverse workforce and we do not make any hiring or employment decisions that could be discriminatory in any way. We have implemented a gender balance and diversity policy.

Duties and Responsibilities Regulatory Requirements Identification and Implementation: Systematically identify legal and regulatory requirements related to Information Security. Implement the technical measurements to ensure Methinks’ processes and products consistently meet these evolving standards. These include, but are not limited to, library updating, vulnerability identification and resolution, effective testing pipeline implementation, or architecture diagram crafting

Gap Analysis and Process Improvement: Evaluate Methinks’ current technical pipeline against compliance requirements, identifying gaps and developing strategies to bridge them effectively.

Interdepartmental Collaboration: Collaborate closely with the regulatory, technology, and product teams to embed compliance and security considerations within Methink’s product development lifecycle, overseeing software and library compliance, and addressing new feature compliance challenges.

Quality Management System (QMS) Compliance: Ensure strict adherence to the defined QMS, focusing on product design, development, risk management, and compliance with standards relevant for Methinks.

Verification and Validation Oversight: Aid in designing and executing product verifications and validations, aligning these efforts with regulatory requirements to ensure full compliance.

Security Posture Coordination: Manage and implement key activities that fortify our security posture, such as disaster recovery planning, contingency plans, SBOM generation and maintenance, penetration testing, threat modeling and vulnerability management.

Policy Development and Implementation: Contribute to the creation of comprehensive policies that integrate the requirements of all relevant regulations, ensuring a unified approach to compliance.

Educational Leadership and Cultural Integration: Lead initiatives to educate the entire Methink’s team on compliance processes, aiming to make adherence to these processes a core part of the company’s culture and everyday work. This includes developing training programs, conducting workshops, and creating resources to enhance company-wide understanding and implementation of compliance standards.

Skills and Qualifications Educational Background:

A Bachelor of Science (BS) degree in a technical or regulatory-related field. This foundational education is essential for understanding the complexities of compliance in the context of software and medical devices. Examples of preferred qualifications include a Software or an Information Security Engineer with interest in transitioning into a more regulatory-oriented role, or a QA specialist with strong information security and coding skills.

Industry-Specific Experience: Proven experience in the software as a medical device (SaMD) industry within the EU and/or US markets. A thorough understanding of the regulatory landscapes and compliance requirements specific to these regions is critical.

Regulatory Experience: Solid experience and familiarity with regulatory frameworks and compliance requirements in the software as a medical device (SaMD) industry, particularly within the EU and/or US markets. This includes navigating regulatory submissions, audits, and adherence to standards like ISO 13485, FDA regulations, and CE marking.

Testing Expertise: Strong background in both static and dynamic testing methodologies in software development, including smoke, unit, integration, stress, and system testing. This expertise is vital for comprehensive software quality assurance.

Technological Proficiency: Good understanding of our technology stack, including Linux, Docker, cloud providers, Python, and PyTorch. While not requiring expert-level knowledge, enough familiarity to comprehend the compliance challenges each component presents is necessary. This experience brings valuable insights into the compliance aspects unique to AI applications in medicine.

Cross-Functional Collaboration: Proven capability in cross-functional coordination and collaboration, effectively bridging regulatory affairs, product development, and technical teams. This competency is crucial for ensuring integrated compliance strategies and facilitating effective communication across various segments of the organization.

English language proficiency required, Spanish language proficiency is a plus.

What can we offer 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.

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Controller / METHINKS SOFTWARE S.L. (METHINKS)

Purpose / Subscribing to the Newsletter.

Legal Bases / Express consent.

Storage Period / The data will be kept for the time necessary to fulfill the purposes collected, as well as for the fulfillment of legal obligations.

Rights / You have the right to request from us access, rectification or erasure of your personal data, the right to restrict processing and object to processing at [email protected].

Additional Information / Additional and detailed information on Data Protection can be found in the attached clauses in Privacy Policy.

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