Freelancer profile translated to English.
Back to original languageAbout Shanyate
I am Shanyate, a specialist in Quality and Regulatory Affairs for innovative medical devices.
I support MedTech and HealthTech companies in their regulatory and quality challenges. With over 14 years of experience in the innovative medical device sector, I specialize in compliance strategies, CE marking, and key standards such as ISO 13485 and IEC 62304. My goal is to facilitate market access while ensuring product safety and performance.
I bring pragmatic and tailored expertise to my clients, guiding them through the complex requirements of the sector. My rigorous and structured approach sustainably supports their competitiveness by integrating regulatory requirements from the initial stages. I am committed to transforming regulatory constraints into strategic opportunities for innovation.
French
Native or bilingual
English
Native or bilingual
Malagasy
Native or bilingual
Can work on-site
Montrouge (up to 50km), Paris (up to 50km), Amiens (up to 50km)
Experience
- QUAMELEOIndependent Consultant in QARA for Innovative Medical DevicesJuly 2025 - Today (11 months)Montrouge, FranceI assist you in developing and implementing effective strategies for:
- Marketing an innovative medical device (MD and IVD)
- Accessing international markets
- Engaging in a quality process to improve company performance and/or obtain certification
My services:- Regulatory strategy
- Regulatory affairs
- Quality Management Systems (QMS)
- Training
- Audits
- Design support
- Risk Management
Areas of expertise:- Management Systems
- ISO 13485
- ISO 9001
- ISO 27001
- 21 CFR Part 820
- ISO 42001
- IEC 62304
- Technical Documentation
- Risk Management
- Regulatory Compliance
- Artificial Intelligence
- Medical Device Cybersecurity
- CE Marking (EU)
- Regulation (EU) 2017/745 (MDR)
- Regulation (EU) 2017/746 (IVDR)
- Medical Device Single Audit Program (MDSAP)
- US Market (FDA) and other countries
- GDPR (EU) and HIPAA (FDA) Compliance
- OwkinSenior Quality and Regulatory Affairs EngineerSeptember 2024 - April 2025 (7 months)Paris, France
- Quality Management
- ISO 13485
- IEC 62304
- Technical Documentation
- CE Marking
- IVDR
- PMS & PMPF Documentation
- FDA "Q-Sub" pre-submission package for a biomarker detection algorithm
- Distributor Management
- QTA Implementation
- Regulatory strategy for AI-based solutions used for clinical trials
- STRATEGIQUAL SAS (Groupe ProductLife)Senior Quality and Regulatory Consultant - MD and IVDSeptember 2022 - August 2024 (1 year and 11 months)Montrouge, France
- Consulting with senior expertise level
- ISO 13485
- IEC 62304
- IEC 60601
- MDR
- IVDR
- Dir. 98/79/EC
- Dir. 93/42/EEC
- Regulatory compliance strategy
- CE Marking
- Technical Documentation
- Transitional period management
- Relations with notified bodies, certification bodies, and authorities
- Audits
- Training
- Workshop facilitation
- Coaching
- Project Management
- Team Management
- Company promotional activities
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Education
- General engineer, Dependability/RAMSInstitut National des Sciences Appliquées Centre Val de Loire2012General engineer, Dependability/RAMS
- DUT, GEIIIUT de Sénart-Fontainebleau2009DUT, GEII
Certifications
- ISO 13485:2016 Quality Management System Standard for Medical DevicesStrategiqual2023
- MDSAP additional requirements to ISO 13485:2016AC Medical Consulting2026