Yassine Ougoudad Email & Phone Number | Highly skilled QARA Manager with extensive experience in ensuring compliance with quality standards and regulatory requirements. Proven track record of implementing effective quality management systems and leading successful audits. Current Skills: - MDD/MDR & IVDD/IVDR transition. - Internal Audit - Project Management - Writing and updating of report, procedure and process related to (UDI, SSCP, PMS, PMCF, Machining, Laser marking, Anodization, Passivation, Sterilization, Biocomp, Shelf-life...). - GAP Analysis - NCs & CAPAs. - Change control - Management of suppliers - Identification of regulatory requirements. - International registration file according to the legislation of the country. - QMS management - KPI performance indicators - Clinical investigation (Research of existing studies + Patents + Proposal of protocols for Cluster & Zelen's clinical trials) Synopsis / ethics committee forms. - Benchmarking comparison of the functionalities of equivalent MDs. - Writing of the specifications for the applications + design (connected MD and normal also) by integrating usability study and all the functionalities as well as the respect of the GDPR and the related risks. - Complaints CRM / PMS/PSUR: Reactive -> Vigilance / proactive ->PMCF/PMPF. - Vigilance reporting (MIR, FSN, FSCA) - retrospective / proactive PMCF / PMPF - Prototyping and 3D design. - ANSM/AMM/HAS/LPPR forms. - MDR 2017/745 / IVDR 2017/746 / 98/79/EC / MDD 93/42 / MEDDEV / FDA / REACH. - ISO13485 / EN-ISO14155 / ISO-IEC60601 / ISO14971 / ISO10993 /ISO15223/ ISO11135 / EN1041 / IEC62366 / IEC62304 / ISO9001 / ISO 80002-1 / ISO 42001 / ISO 81001-5-1 - VSI : IQ, OQ, PQ, DS/FS/URS. - CTQ validation tests: IQ, OQ, PQ, DS/FS/URS.

Yassine Ougoudad

Highly skilled QARA Manager with extensive experience in ensuring compliance with quality standards...
Paris, Paris, France

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Yassine Ougoudad’s Email yassine.ougoudad@eforgroup.fr

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Yassine Ougoudad’s Location Paris, Paris, France

Yassine Ougoudad’s Current Industry Spimed Ai

Yassine Ougoudad’s Prior Industry Echosens Bforcure Balt Novaspine Biophoton Toulouse Inserm Cellule R And D Hacking Health Camp Pole Des Microtechniques Eit European Isifc Sofcot Officiel Claes Universite Medicalexpo Bmce Bank Efor | | | | | | | | | | Institute Of Innovation And Technology | | | Medical Service Groupe | Internationale Abulcasis Des Sciences De La Sante Uiass | |

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Work Experience

Spimed Ai

QARA Manager / PRRC

2023-05-01 00:00:00 - Present

Efor

Medical Device consultant

2020-10-01 00:00:00 - 2023-09-01 00:00:00

Echosens

RA Manager Consultant

2022-11-01 00:00:00 - 2023-05-01 00:00:00

Bforcure

QA/RA Consultant Manager

2021-11-01 00:00:00 - 2022-11-01 00:00:00

Balt

QA/RA Consultant

2021-04-01 00:00:00 - 2021-11-01 00:00:00

Novaspine

QA/RA Consultant

2020-10-01 00:00:00 - 2021-04-01 00:00:00

Biophoton Toulouse

Quality Assurance & Regulatory Affairs officer

2020-03-01 00:00:00 - 2020-09-01 00:00:00

Inserm

R&D Officer (CHRU Jean Minjoz)

2019-10-01 00:00:00 - 2020-02-01 00:00:00

Cellule R And D

R&D / Clinical / QA / RA

2019-03-01 00:00:00 - 2019-10-01 00:00:00

Hacking Health Camp

Participant

2019-10-01 00:00:00 - 2019-10-01 00:00:00

Pole Des Microtechniques

Participant à La Rentrée du DM

2019-09-01 00:00:00 - 2019-09-01 00:00:00

Eit European Institute Of Innovation And Technology

R&D

2019-07-01 00:00:00 - 2019-07-01 00:00:00

Isifc

Regulatory affairs

2018-10-01 00:00:00 - 2019-01-01 00:00:00

Sofcot Officiel

Participant

2018-11-01 00:00:00 - 2018-11-01 00:00:00

Claes Medical Service Groupe

Assistant Internship

2018-06-01 00:00:00 - 2018-08-01 00:00:00

Universite Internationale Abulcasis Des Sciences De La Sante Uiass

Bachelor’s project

2017-09-01 00:00:00 - 2018-05-01 00:00:00

Medicalexpo

Participant

2017-03-01 00:00:00 - 2017-03-01 00:00:00

Bmce Bank

Stagiaire marketing

2013-06-01 00:00:00 - 2013-07-01 00:00:00

Skills

No Skills Available

Languages

No Languages Available

FAQ About Yassine Ougoudad

Yassine Ougoudad is located at
Paris, Paris, France

Yassine Ougoudad is a Highly skilled QARA Manager with extensive experience in ensuring compliance with quality standards and regulatory requirements. Proven track record of implementing effective quality management systems and leading successful audits. Current Skills: - MDD/MDR & IVDD/IVDR transition. - Internal Audit - Project Management - Writing and updating of report, procedure and process related to (UDI, SSCP, PMS, PMCF, Machining, Laser marking, Anodization, Passivation, Sterilization, Biocomp, Shelf-life...). - GAP Analysis - NCs & CAPAs. - Change control - Management of suppliers - Identification of regulatory requirements. - International registration file according to the legislation of the country. - QMS management - KPI performance indicators - Clinical investigation (Research of existing studies + Patents + Proposal of protocols for Cluster & Zelen's clinical trials) Synopsis / ethics committee forms. - Benchmarking comparison of the functionalities of equivalent MDs. - Writing of the specifications for the applications + design (connected MD and normal also) by integrating usability study and all the functionalities as well as the respect of the GDPR and the related risks. - Complaints CRM / PMS/PSUR: Reactive -> Vigilance / proactive ->PMCF/PMPF. - Vigilance reporting (MIR, FSN, FSCA) - retrospective / proactive PMCF / PMPF - Prototyping and 3D design. - ANSM/AMM/HAS/LPPR forms. - MDR 2017/745 / IVDR 2017/746 / 98/79/EC / MDD 93/42 / MEDDEV / FDA / REACH. - ISO13485 / EN-ISO14155 / ISO-IEC60601 / ISO14971 / ISO10993 /ISO15223/ ISO11135 / EN1041 / IEC62366 / IEC62304 / ISO9001 / ISO 80002-1 / ISO 42001 / ISO 81001-5-1 - VSI : IQ, OQ, PQ, DS/FS/URS. - CTQ validation tests: IQ, OQ, PQ, DS/FS/URS. - GMP / GCP / GLP

Yassine Ougoudad currently works in the Spimed Ai |

No Languages Available

Yassine Ougoudad has prior
experience in the following industries:
Efor | Echosens | Bforcure | Balt | Novaspine | Biophoton Toulouse | Inserm | Cellule R And D | Hacking Health Camp | Pole Des Microtechniques | Eit European Institute Of Innovation And Technology | Isifc | Sofcot Officiel | Claes Medical Service Groupe | Universite Internationale Abulcasis Des Sciences De La Sante Uiass | Medicalexpo | Bmce Bank

Yassine Ougoudad has the following professional experience:
Spimed Ai | Efor | Echosens | Bforcure | Balt | Novaspine | Biophoton Toulouse | Inserm | Cellule R And D | Hacking Health Camp | Pole Des Microtechniques | Eit European Institute Of Innovation And Technology | Isifc | Sofcot Officiel | Claes Medical Service Groupe | Universite Internationale Abulcasis Des Sciences De La Sante Uiass | Medicalexpo | Bmce Bank

You can view Yassine Ougoudad’s LinkedIn profile at LinkedIn URL

Yassine Ougoudad’s work email
addresses are
yassine.ougoudad@eforgroup.fr

Spimed Ai |