Ceo And Co-Founder
CurrentAfter Brexit, EMD UK is now the UK Responsible Person for Medical Device manufacturers that want to continue business in England.
Nov 2020 - Present
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Monir El Azzouzi Email & Phone Number
Founder & CEO at Easy Medical Device | Consulting Firm | Podcast Host
at
Easy Medical Device
1 work email found
@jnj.com
LinkedIn matched
✓ Verified Jul 2026
4 data sources
Profile completeness 100%
Current company
Role
Founder & CEO at Easy Medical Device | Consulting Firm | Podcast Host
Location
Basel Metropolitan Area, Switzerland
Who is Monir El Azzouzi? Overview
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Quick answer
Monir El Azzouzi is listed as Founder & CEO at Easy Medical Device | Consulting Firm | Podcast Host at Easy Medical Device, based in Basel Metropolitan Area, Switzerland. AeroLeads shows a work email signal at jnj.com and a matched LinkedIn profile for Monir El Azzouzi.
Monir El Azzouzi previously worked as CEO and Co-Founder at Easy Medical Device and Founder & CEO at Easy Medical Device. Monir El Azzouzi holds Bac+5, Ingenieur Biomedical from Isifc - Ecole D'Ingénieur Biomédical.
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Email format at Easy Medical Device
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*@jnj.com
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Profile bio
About Monir El Azzouzi
My wish is to support the needs of pharmaceutical and medical devices companies to reach their objectives and to help patients to obtain the product they need. I've acquired during my career sufficient knowledge to drive projects related to quality and regulatory affairs and had experienced many successes but also some difficulties which helped me to learn more.To start that journey I created EasyMedicalDevice.com which is here to bring some awareness on all the new regulations transitions that are ongoing.As you can see by the name of the site, the objective is to make the Medical Device Regulations and Standards easy to understand. Read my blog posts and look at my Youtube channel and subscribe to my podcast (Medical Device made Easy) so you can learn how to place a compliant medical device on the market.My Motto is: "WOULD I GIVE THIS PRODUCT TO A MEMBER OF MY FAMILY?" so don't forget that health is one of the most important pieces of your life. Don't destroy it.About me:For my background, I am specialized in Quality and Regulatory Affairs for Medical Devices and also have some experience in Medicinal Products. This helped me to acquire knowledge of combination products and borderline products.Below are some of the standards and regulations I practiced:For devices - Medical Device Directive MDR 2017/745, IVDR 2017/746, MDD 93/42/EC, 98/79/EC for IVD, FDA 21CFR 820, ANVISA, JPAL and 510K registration, ISO 13485:2016, ISO 14971.Related to drug - I follow Drug Directive 2001/83/EC.Additionally, I drove some Process improvement (Change management, PDCA, CAPA)Lean manufacturing (SMED (Pit stop), Value Stream Mapping, 5S, 6 sigmas)
Listed skills include Capa, Regulatory Affairs, Fda, Iso 13485, and 42 others.
Current workplace
Monir El Azzouzi's current company
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13 roles
Monir El Azzouzi work experience
A career timeline built from the work history available for this profile.
Founder & Ceo
CurrentCompany helping Medical Device Manufacturers to learn about Medical Device Regulation and standards.- Offering consulting services on the area of Quality and Regulatory affairs. - EU Authorized Representative- UK Responsible Person- Blog: https://easymedicaldevice.com/blog- Youtube Channel - http://www.youtube.com/c/EasyMedicalDevice- Podcast - Medical Device made Easy - https://podcast.easymedicaldevice.comWe provide support for people and companies who want to learn how to place a compliant Medical Device on the Market. Don't hesitate to contact us if you need some more information on the website or its content.
Mar 2018 - Present
Co-Founder & Managing Director
CurrentS-Cube Technologies is offering an eQMS that is helping companies to stay compliant.- Support for Customer Growth- Create an amazing experience with customers- Improve features within the eQMS- Update eQMS to always be aligned with legislation- Perform Demos to customers
Jul 2023 - Present
Quality Operation Manager
Management of the Quality Engineering team on 2 sites with the objective of:- Process Validation- Problem Solving- Improvement- Introduction of New Products- Introduction of New Technologies (Additive manufacturing or 3D-Printing, Injection Molding)
Mar 2018 - Sep 2019
Plant Quality Senior Manager
Quality person responsible of 3 production sites with orthopaedic Implants and Instruments.- Quality System section in charge of Document Control, metrics reporting and support of Audit readiness.- Quality Engineering section in charge of process improvement, validation and problem investigation.- Inspection and calibration section in charge of product control and calibration of measurment equipment.High collaboration with Sterility Assurance, Supplier Quality and CSV (Computer System Validation)
Jul 2016 - Mar 2018
Plant Quality Manager
Management representative.Responsible for Quality Operation:- Process Validation and engineering- Inspection & Calibration - Quality SystemProducts: Orthopaedic implants and instruments for traumatology, spine and cranio-maxilo-facial.Certification: ISO 13485, CE mark, FDA, ANVISA, JPAL
Jan 2016 - Jun 2016
Quality And Regulatory Compliance Manager
- Leader for the EMEA Quality and Regulatory Compliance - Management Representative and leader during Third Party audit- Leading the group for Complaint management in collaboration with EMEA Technical Service- Certification for ISO 13485 - 21 CFR 820, MDD 93/42/EC for Medical Devices- Part of EUCOMED, SNV organizations- Reporting to US headquarter
Oct 2013 - Dec 2015
Regulatory Affairs Manager, Global
Management of a portfolio of pharmaceutical and medical devices products.Coordination of the products registration all over the world.RA leader for new product development, CTA submissionsManagement of Borderline products (Class III) - Medical devices containing an ingredient that could be considered a drug.Dealing with health authorities (Bfarm, AFSSAPS, MHRA, TUV, MDC...) for the submissions, variation, renewal, deficiency letters...
Oct 2011 - Sep 2013
Head Of Quality And Regulatory Affairs
Management of 2 departements with 6 direct reports and 12 Quality inspectors- Quality department divided on Quality Management System (QMS), Design control, Suppliers management and compliance management.- Regulatory Affairs with Technical file management (development and lifecycle).- Management of products registered in the US under 510k.Certification ISO 13485 - 9001, FDA et RDC, Brazil (ANVISA), Taïwan
Mar 2010 - Sep 2011
Quality And Regulatory Affairs Manager
- Quality system and Regulatory management for medical devices from class I to class III (Knee implants) - ISO 13485 + Directive 93/42/EC (2007/47/EC)- Implementation of a new CAPA system to make it more practical- Internal, supplier and Third party audit management.- Process Validation IQ OQ PQ for manufacturing machines. Six sigma, lean manufacturing.- Project management for the investment of an Ultrasound washing machine for implants
Sep 2008 - Mar 2010
Process Validation Engineer
Problem solving (Brainstorming, ischikawa, pareto, FMECA...)ISO 13485 and FDA for the process validation (IQ, OQ, PQ).Internal and external auditor.Product risk managementProject leader for machine investmentManagement of non-conformity
Oct 2006 - Sep 2008
Biomedical Engineer
Micro Mega
I am actually the help of the Quality Manager. I organize all about Directive 93/42/ce with the ISO 13485 and also the Canadien laws.I Manage all the system of the entreprise. Training for the project Manager and Improvement of the performances.
Mar 2006 - Sep 2006
Biomedical Engineer
Micro Mega
CE marking of medical devices instruments.MDD 93/42/CEISO 14971ISO 13485
Mar 2005 - Aug 2005
3 education records
Monir El Azzouzi education
Bac+5, Ingenieur Biomedical
Isifc - Ecole D'Ingénieur Biomédical
Bac+5, Master
Université De Franche Comté - Master Qualité Et Management Des Performances
Bac+1, Faculté De Médecine
Université De Franche-Comté
FAQ
Frequently asked questions about Monir El Azzouzi
Quick answers generated from the profile data available on this page.
What company does Monir El Azzouzi work for?
Monir El Azzouzi works for Easy Medical Device.
What is Monir El Azzouzi's role at Easy Medical Device?
Monir El Azzouzi is listed as Founder & CEO at Easy Medical Device | Consulting Firm | Podcast Host at Easy Medical Device.
What is Monir El Azzouzi's email address?
AeroLeads has found 1 work email signal at @jnj.com for Monir El Azzouzi at Easy Medical Device.
Where is Monir El Azzouzi based?
Monir El Azzouzi is based in Basel Metropolitan Area, Switzerland while working with Easy Medical Device.
What companies has Monir El Azzouzi worked for?
Monir El Azzouzi has worked for Easy Medical Device, S-Cube Technologies, Johnson & Johnson, Bausch + Lomb, and Scient'X.
How can I contact Monir El Azzouzi?
You can use AeroLeads to view verified contact signals for Monir El Azzouzi at Easy Medical Device, including work email, phone, and LinkedIn data when available.
What schools did Monir El Azzouzi attend?
Monir El Azzouzi holds Bac+5, Ingenieur Biomedical from Isifc - Ecole D'Ingénieur Biomédical.
What skills is Monir El Azzouzi known for?
Monir El Azzouzi is listed with skills including Capa, Regulatory Affairs, Fda, Iso 13485, Medical Devices, Quality System, Validation, and Ansm.
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