Senior QARA Engineer
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- Ensure the compliance and robustness of the software medical device throughout its lifecycle.
- Integrate quality and regulatory requirements from the design stage and throughout the development lifecycle.
- Maintain and improve the quality management system (QMS) and its operational practices.
- Prepare and maintain regulatory documentation, including technical files and compliance evidence.
- Contribute to post-market surveillance (PMS) activities and interfaces related to clinical studies.
- Structure complaint tracking and lead the associated CAPAs.
- Collaborate with Product, Clinical, Security, and Support teams to make pragmatic decisions.
- Contribute to the continuity of critical activities, including maintaining market access, certifications, and clinical research support.
Requirements
- 5 years of experience in regulatory affairs and/or quality for medical devices under the MDR, ideally in software or healthcare.
- Experience contributing to the maintenance or improvement of a QMS (ISO 13485).
- Experience with technical files and regulatory documentation under the MDR.
- Participation in post-market activities (PMS) and/or complaint management.
- Ability to work on QARA and compliance topics related to medical devices, ideally SaMD.
- Proficiency in a risk-based approach, such as ISO 14971, and the ability to translate it into requirements and evidence.
- Ability to produce clear, structured, audit-ready documentation.
- Ability to collaborate with Product and Tech teams from the design stage.
- Operational proficiency in written and spoken English.
- Rigorous, detail-oriented, self-directed, and solution-oriented.
- Ability to challenge constructively and build consensus without formal authority.
- Strong prioritization skills, pragmatism, reliability, and a cross-functional mindset.
- Knowledge of topics at the intersection of quality and information security, such as ISO 27001, is a plus.
- Experience working in international environments is a plus.
- Experience with clinical studies is a plus.
Core Competencies
Demonstrates expertise in regulatory affairs and quality management for medical devices, with a strong focus on compliance, documentation, and post-market surveillance. Proficient in maintaining quality management systems and collaborating across teams to ensure product integrity and market access.
Highest-signal resume keywords
- Regulatory Affairs Experience
- Quality Management System (ISO 13485)
- Technical Documentation Under MDR
- Post-Market Surveillance (PMS)
- Risk-Based Approach (ISO 14971)
Hard Skills
- Regulatory Documentation
- Quality Management System (QMS)
- Complaint Management
- Post-Market Activities
- Risk Assessment
- Audit-Ready Documentation
- Software as a Medical Device (SaMD)
- ISO 27001 Knowledge
- Clinical Studies Experience
- MDR Compliance
Soft Skills
- Detail-Oriented
- Self-Directed
- Solution-Oriented
- Strong Prioritization Skills
- Cross-Functional Mindset
Industry Keywords
- Medical Devices
- Quality Assurance and Regulatory Affairs (QARA)
- Compliance
- Clinical Research
- International Environments
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