We are looking for an empathic and driven QA/RA Manager to join our team!
As our first QA/RA Manager you will collaborate with everyone in the Elsa organisation and lead the work to make sure we comply with regulatory requirements and effectively improve our quality. You will be responsible for Elsa Science’s Quality Management System and need to make sure Elsa is compliant with the laws, regulations and standards for medical devices in various markets.
Your day-to-day will include
- Develop, implement and maintain Elsa Science’s Quality Management System (QMS)
- Train the organisation
- Support writing SOP-documents.
- Control and keep the Technical File up to date
- Facilitate Risk Management, Verification and Validation sessions
- Perform internal audits
- A calling to impact people's lives for the better
- Excellent written and verbal communication skills in English
- Ability to solve regulatory problems in new and innovative ways
- At least 4 years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
- Excellent leadership skills, conflict resolution, assertiveness, negotiation and influence management
- Interest in Digital Health to deliver improved clinical outcomes
- Knowledge or experience in Medical Device standards and regulations like ISO 13485, ISO 14971, IEC 62304 and IEC 62366, MDD/MDR and FDA CFR Title 21 Part 11 and 820
- Good understanding of ISO 27001, GDPR and other privacy and data protection standards
It would be amazing if you have
- Experience withSoftware as a Medical Device (SaMD) and Mobile Medical Applications
- Understanding of the requirements for Clinical Evaluation according to MEDDEV 2.7.1 Rev 4 and the changes under the MDR
- Experience in GCP specifically relating to Electronic Data Capture
QMS, MDR, ISO 13485, IEC 62304