Your Mission

Under the supervision of your tutor, you will ensure the operational continuity of the QARA department:

• QMS Operational Excellence: Manage and follow up on Non-Conformities (NC) , CAPAs and improvements actions

• Change Control: Participate in managing technical changes

• Supplier and tool qualification: Evaluate and monitor providers and tools

• Regulatory Intelligence: Monitor and analyze regulatory updates (MDR 2017/745, MDCG guidance, AI Act).

• Technical Documentation: Support the maintenance of Technical Files for our 3 CE-marked devices.

Profile Requirements

Education: Currently pursuing a Master’s degree (Year 1 or 2) or PharmD, specialized in Quality, Regulatory Affairs, or Health Engineering.

• Expertise: Solid knowledge of ISO 13485 and the Medical Device Regulation (MDR).

• Digital Savvy: Strong interest in Software as a Medical Device (SaMD) and numeric tools

• Languages: Fluent in French and proficient in Professional English.

Soft Skills

• Communication & Adaptability: Ability to bridge the gap between complex regulatory requirements and daily operational discussions with Tech teams.

• Problem-Solver Mindset: You don’t just identify gaps or "red flags"; you actively propose compliant and pragmatic solutions to unblock operational situations.

• Rigor & Agility: High attention to detail combined with the ability to navigate a fast-paced scale-up environment.

GDPR : Your personal data will be processed for the purposes of recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. They will be available only for people involved in the process and erased after 2 years of inactivity.

Under GDPR and as Resilience attach great importance to privacy, please note that you have the right to request access to your personal data, to request that your personal data be rectified or erased. The Data Protection Officer can be contacted at privacy@resilience.care

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