Quality Assurance

Company Description

The Quality Assurance & Regulatory Officer (QARO) plays a hands-on role within ELEM’s Quality and Regulatory Affairs.

ELEM is a cutting‑edge in silico startup developing virtual human digital twin technology to transform the future of healthcare. To learn more, visit http://elem.bio.

As part of our Compliance team, the QARO ensures that our solutions, processes, and documentation meet all applicable quality and regulatory requirements.

Role Description

1. Design, Development & Technical Documentation:

- Actively participate in design and development activities to ensure ELEM Solutions complies with applicable standards.
- Contribute directly to the creation, completion, and maintenance of technical documentation.

2. Quality Control, Non‑Conformities & Continuous Compliance:

- Handle non‑conformities and deviations end‑to‑end, including documentation, investigation, and root cause analysis.
- Define, implement, and routinely monitor quality controls throughout the product lifecycle.
- Conduct activities to ensure ongoing compliance with ISO 13485 and IVDR.
- Review and confirm that manufactured software versions meet conformity requirements before market release.

3. Document Control, Traceability & Complaint Handling:

Manage traceability, storage, and controlled handling of quality documents and complaints.

4. Regulatory Monitoring & Documentation:

- Monitor changes to regulatory and normative requirements and communicate relevant updates to internal teams.
- Prepare, compile, and submit regulatory documentation to relevant authorities and stakeholders.
- Build and maintain working relationships with regulatory stakeholders while responding directly to inquiries from notified bodies, competent authorities, and other relevant parties.

5. Product Release & Market Readiness:

- Perform hands‑on product release activities and verify compliance with ISO 13485 and EU IVDR requirements.

6. Audits, Inspections & QMS Maintenance:

- Prepare, coordinate, and support QMS audits and inspections, serving as the primary point of contact throughout the process.
- Maintain and update the post‑market surveillance and vigilance system, ensuring timely documentation and follow‑up.

7. Reporting & Performance Monitoring:

- Provide clear reporting on QMS performance, compliance status, and opportunities for improvement.
- Training, Culture & Cross‑Functional Support:
- Develop and deliver practical training to ensure staff understand quality and regulatory requirements.
- Support cross‑functional teams in fostering a strong culture of quality, compliance, and continuous improvement.

Qualifications

Technical Requirements and Skills:

- Proficiency in Quality Assurance principles, ISO 13485:2016 requirements, and the practical maintenance of a QMS.
- Applied knowledge of IVDR/MDR and relevant regulatory guidelines (EMA, FDA, and others), including hands-on experience with regulatory filings and product registration processes.
- Practical understanding of software product development workflows; experience with biomedical or health‑related software is an advantage.

Education and Experience Requirements:

- University degree in a life science or a related discipline such as engineering, pharmacy, or another relevant scientific field.
- Additional training or certification in quality assurance and/or regulatory affairs.
- 2+ years of industrial experience in quality assurance, process management, regulatory affairs, or QMS activities related to medical devices.
- Fluency in English, both written and spoken.
- Strong proficiency with Microsoft Office and related productivity tools.
- Ability to use AI tools effectively.

Desirable qualifications for the position:

- Advanced degree in Life Sciences, Engineering, Business, or related field (Master or PhD).