RAQA (Compliance Officer)
RAQA (Compliance Officer)
We're building something that matters. Enaiblers has developed an AI-powered portable microscope that delivers lab-grade diagnostic accuracy anywhere — replacing the need for expert microscopists across diseases affecting 1.5 billion people. With clinical validation across four countries, 6 peer-reviewed publications, and a spot on Ny Teknik's 33 List of Sweden's most promising startups, we're now preparing for market entry through ISO 13485 implementation and CE marking. We need someone who can own that journey with us.
We're looking for a Regulatory Affairs & Quality Assurance Specialist to join our small, multidisciplinary team and play a central role in building our quality management system, preparing regulatory dossiers, and bringing this platform to patients who need it.
What You'll Do
- Build and own the QMS — establish, maintain, and improve our quality system (ISO 13485), including document control, SOPs, and quality records
- Drive regulatory strategy — support EU market entry and CE marking; prepare Technical Documentation, Risk Management Files (ISO 14971), and supplier evaluations
- Manage compliance operations — track CAPAs, non-conformities, and root cause analyses; coordinate internal and external audits
- Be the quality voice — advise the development team on regulatory matters, train colleagues, and ensure everyone understands their role in quality
- Support market access — navigate EUDAMED, Notified Body engagement, and international approval processes (including WHO frameworks)
- Improve continuously — refine processes, documentation, metrics, and reporting as we grow
What We're Looking For
- 3+ years in Regulatory Affairs or Quality Assurance in the EU medical device industry, ideally with medical software (SaMD / digital health)
- Practical experience with EU MDR, ISO 13485, ISO 14971, IEC 62304, and IEC 62366
- Understanding of CE marking processes, Technical Documentation, and software classification under MDR
- Familiarity with PMS, vigilance, CAPA, and deviation management
- Comfortable working with development teams, including Agile workflows aligned with IEC 62304
- Relevant education in product development, quality, or a related field — with an understanding of both hardware and software
- Strong documentation skills and excellent English (spoken and written)
- Structured, detail-oriented, and not afraid to hold people accountable
Bonus Points
- Experience with AI/ML-based medical software, IEC 81001-5-1, EU AI Act, or EU IVDR
- Certified Internal Auditor (ISO 13485) or experience conducting audits
- Experience with Clinical Evaluation or Post-Market Clinical Follow-up (PMCF)
Why Enaiblers?
We're a team of 5, founded in 2022, and we've already validated our technology in real clinical settings across four countries. We're now selling for research use and working toward IVDR and WHO regulatory approval. You'll join at the stage where your work defines how we scale — with real ownership, real impact, and a product that genuinely changes lives.
Salary: Monthly
Terms: Permanent full-time, 6-month probationary period
Curious? Apply now or reach out — we'd love to hear from you
Questions: peter.ward@enaiblers.com
