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).
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