We are seeking a Quality and Regulatory Affairs Specialist to join our team at QYNAPSE. Reporting to the Quality and Regulatory Affairs Director, your main missions will be the following:

Supporting the Quality System management of the company:

• Supporting quality management system continuous improvement in accordance with the applicable regulations and standards (ISO 13485, FDA 21 CFR, etc.).

• Adapting the QMS to international requirements.

• Writing and updating documents necessary for the Quality Management.

• Handling non-conformities and implementing corrective action plans.

• Promoting a Quality culture and transmitting QARA expectations to Qynapse team members.

• Training and supporting the entire team in maintaining good practices and using the Quality Management System.

• Providing support for inspections and audits (suppliers, internal, and certification).

Ensuring that regulatory requirements are fulfilled for the medical devices designed by the company:

• Supporting design control deliverables and activities related to product development projects.

• Taking part in preparing registration files (USA, Europe) and regulatory activities related to product development and/or product modification.

• Performing continuous surveillance of applicable standards and regulations.

• Participating in Post-Market Surveillance activities.

This position will include close interactions with the Data Science, Imaging, Development, and Clinical research teams at Qynapse.

PROFILE:

• Master of Science degree, with a focus on Quality Management and/or regulatory affairs for medical devices.

• Familiarity with medical device-related standards and regulations, including MDR 2017/745, ISO 13485, ISO 14971, 21 CFR, and 510(k).

• Efficient, focused, organized, and autonomous.

SKILLS & EXPERIENCE:

REQUIRED:

• Experience with applicable European standards: ISO 13485:2016 and regulation EU 2017/745.

• Experience with 21 CFR Part 820 Quality System Regulation and expertise in the regulatory pathway for FDA clearance.

PLUS, AT LEAST ONE OF THE FOLLOWING:

• Experience with ISMS and HDS.

• Experience with medical device software.

• Experience with imaging or neuro-imaging technologies.

• Knowledge of international regulatory requirements.

• Familiarity with the General Data Protection Regulation (GDPR) and HIPAA.

• Experience in data science and predictive algorithms.

LANGUAGES:

• English.

• French (is a plus but not required).