Quality and Regulatory Affairs Specialist

Job summary
Permanent contract
Salary: Not specified
A few days at home
Skills & expertise
Quality management
Regulatory compliance


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Questions and answers about the job

The position

Job description

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.

Preferred experience


  • 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.



  • 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.


  • 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.


  • English.

  • French (is a plus but not required).

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