Open to opportunities

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@gl0

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Experienced QA & RA executive specializing in medical devices.

Israel

Message

What I'm looking for

I seek a role that values quality and compliance, offering growth opportunities in the medical device sector.

I am a QA & RA executive with over 20 years of experience in class II/III medical devices, combination products, and pharmaceuticals. My expertise includes ISO 13485/MDSAP lead auditing, having completed 15 audits across various regions including Israel, Europe, and the United States. I specialize in cardiovascular implants, particularly TAVI, and have a proven track record in implementing electronic Quality Management Systems (eQMS), authoring CE MDR technical files, and managing pre-clinical GLP animal studies.

Throughout my career, I have successfully designed and managed GLP animal studies, implemented ISO 13485 compliant R&D processes, and led supplier audits that significantly reduced non-conformities. My roles have included VP of QA/RA at Xcardia Innovation, where I authored critical technical documentation and optimized sterilization processes, and as an Independent QA/RA Consultant, delivering compliance assessments for startups. I am committed to ensuring quality and regulatory compliance while fostering innovation in the medical device industry.

Experience

Work history, roles, and key accomplishments

Current

QA & Pre Clinical Manager

Current

BeWeld Medical

Nov 2024 - Present (9 months)

Designed and managed GLP animal studies for TAVI, ensuring compliance with ISO 10993-6 and ISO 5840 standards. Implemented ISO 13485 compliant R&D processes and developed a comprehensive Design History File (DMR).

GLP ISO 10993 6 ISO 5840 ISO 13485

VP QA/RA

Xcardia Innovation (MDSG Group)

Mar 2023 - Present (2 years 5 months)

Authored 510(k) and CE MDR technical files for a Class IIb cardiac mapping catheter. Validated ETO sterilization and environmental controls, reducing release time by 20%.

510(K)Greenlight Guru EQMS

QA/RA Consultant

Independent QA/RA Consultant

Apr 2022 - Present (3 years 4 months)

Delivered ISO 13485 gap assessments and supplier audits for two startups. Ensured QMS compliance and business continuity for clients.

ISO 13485 Business Continuity

VP QA/RA

TavTech Medical Device

Jan 2016 - Present (9 years 7 months)

Managed a QA/QC team of two and oversaw ISO 7 cleanroom production for TAVI accessories. Secured MDSAP approval via an on-site audit and maintained CE & ISO 13485 during annual audits.

MDSAP CE Marking ISO 13485

Pharmaceutical Project Management

PolyPid

Jan 2008 - Present (17 years 7 months)

Managed pharmaceutical projects, including IND preparation and preclinical study oversight. Oversaw CMO scale-up activities.

IND Preparation Preclinical Study Oversight Pharmaceutical Project Management

Pharmaceutical Project Management

InSight

Jan 2008 - Present (17 years 7 months)

Managed pharmaceutical projects, including IND preparation and preclinical study oversight. Oversaw CMO scale-up activities.

IND Preparation Preclinical Study Oversight Pharmaceutical Project Management

Pharmaceutical Project Management

Sol Gel

Jan 2008 - Present (17 years 7 months)

Managed pharmaceutical projects, including IND preparation and preclinical study oversight. Oversaw CMO scale-up activities.

IND Preparation Preclinical Study Oversight Pharmaceutical Project Management

Procurement Project Manager

Teva Pharmaceutical Industries

Jan 2004 - Present (21 years 7 months)

Built supplier qualification processes that were adopted across EU/US sites. Managed procurement projects with a \u20ac100M spend.

Education

Degrees, certifications, and relevant coursework

College of Management, Israel

MBA, Business Administration

Completed a Master of Business Administration program, gaining expertise in management principles and business strategies relevant to various industries.