Rabii B.

Maintenance and improvement of the Quality and Environmental Management System (ISO 13485 and ISO 14001 certifications),

Ensuring compliance with current regulations and ISO standards (EU Regulation 217/745, 21 CFR, ISO 13485, ISO 14001),

Ensuring product registration with regulatory bodies according to the legal and regulatory requirements of the respective countries (product registration in 50 countries),

Analyzing the impact of changes to the company's products according to regulatory requirements in different countries,

Participation in external audits (ISO 13485, ISO 14001, Lab) and inspections (FDA, NRTL, INMETRO),

Organizing, planning, and implementing internal and subcontractor audits, Managing DHF/DMR,

Reviewing and controlling DHRs for product release,

Ensuring finished product compliance,

Managing non-conformities and complaints,

Approving and monitoring the implementation of CAPAs,

Participating in Project Core Teams as the Quality and Regulatory representative throughout the projects.

Participation in the maintenance and improvement of the Quality Management System according to current standards and regulations: ISO 13485:2016, 21 CFR 820, 2017/745 MDR.

Management of the Quality Management System's document management activities.

Review of DHRs for device release.

Management of non-conformity processes, leading the CAPA process with CAPA Board meetings, management reviews, and other data analysis activities for continuous improvement.

Development, control, measurement, and communication of quality system performance indicators through various process owners (KPIs).

Raising awareness of Quality and continuous improvement principles among all personnel through training activities.

Raising awareness among teams regarding requirements and preparation for internal, external, and supplier audits.

Maintenance and improvement of the ISO 13485 certified QMS. Management of change control, non-conformities, customer complaints, CAPA, Technical Documentation (TD).

Ensuring product compliance (Class IIa) according to applicable electro-medical device standards (MDR 2017/745 / IEC 60601 series).

Definition of the regulatory strategy for product registration in international markets.

Management of audits (internal, external, subcontractors).

Coordination of Post-Market Surveillance (PMS) for the product (launch studies, clinical studies with a CRO).

Implementation of the MDSAP program for international development.