Hany Abdallah

Sector: Medical Devices – Hemodialysis Catheters (Short & Long Term), Peritoneal Dialysis Catheters, Central Venous Catheters, Urology Catheters, Sheath Introducers, and Accessories. Duties and Responsibilities: o Lead the design and development of new medical devices and enhancements to existing products. o Evaluate new materials, technologies, and processes for potential integration into product lines. o Guide risk analysis, design verification/validation, and usability engineering activities. o Plan, execute, and manage product development projects within defined timelines and budgets. o Coordinate cross-functional teams including R&D, QA, QC/RA, manufacturing, and marketing. o Track milestones and deliverables; identify and resolve technical or resource bottlenecks. o Ensure all product development activities comply with applicable global regulations (e.g., FDA 21 CFR Part 820, ISO 13485, MDSAP and MDR). o Support technical file preparation, risk management documentation, and design history files. o Collaborate with Regulatory Affairs to ensure successful submissions and audits. o Oversee the development and qualification of new manufacturing processes and tooling. o Manage design transfer from R&D to production, ensuring robust process scalability and repeatability. o Lead, mentor, and develop the technical development team; foster a culture of innovation and accountability. o Identify talent gaps and implement training plans to support continuous skill development. o Contribute to strategic planning related to product pipeline, market trends, and competitive analysis. o Partner with business development and marketing to align technical capabilities with market needs. o Act as a subject matter expert in resolving complex technical challenges during product development or post-market activities. o Support post-market surveillance by investigating field issues and recommending design improvements.

Sector: Medical Devices – Hemodialysis Catheters (Short & Long Term), Peritoneal Dialysis Catheters, Urology Catheters, Central Venous Catheters, Sheath Introducers, and Accessories Duties/Responsibilities: o Develop and implement regulatory strategies to support new product development, product changes, and international market expansion. o Interpret and communicate regulatory requirements to internal stakeholders to ensure proactive compliance from early development stages. o Prepare, review, and submit regulatory submissions including: • FDA 510(k) • EU Technical Documentation (MDR) o Ensure timely approval of products and respond effectively to questions or deficiencies raised by regulatory authorities. o Participate in design control processes, providing regulatory guidance during concept, development, verification, validation, and launch phases. o Define regulatory requirements for product labeling, claims, testing, biocompatibility, and clinical evaluations. o Ensure risk management (ISO 14971) and usability engineering (IEC 62366) are integrated into development processes. o Ensure ongoing compliance with applicable regulations. o Support internal and external audits and inspections. o Oversee regulatory impact assessments for product or process changes (Change Control). o Monitor and interpret global regulatory changes and assess their impact on the company’s product portfolio. o Maintain regulatory files, technical documentation, and Design History Files (DHF) in audit-ready condition. o Maintain registration databases, regulatory status trackers, and labeling compliance systems. o Work closely with R&D, Quality Assurance, Manufacturing, Marketing, and Clinical Affairs teams to align regulatory strategies. o Provide regulatory input for customer inquiries, tenders, and distributor support. o Lead and mentor regulatory affairs team members. o Develop regulatory training programs and raise awareness of compliance requirements across departments.

Sector: Medical Devices – Hemodialysis Catheters (Short & Long Term), Peritoneal Dialysis Catheters, Central Venous Catheters, Urology Catheters, Sheath Introducers, and Accessories.

Sector: Medical Devices – Hemodialysis Catheters (Short & Long Term), Peritoneal Dialysis Catheters, Urology Catheters, Central Venous Catheters, Sheath Introducers, and Accessories Job description: The Regulatory Affairs Manager is responsible for leading and managing all regulatory activities related to medical device products, ensuring full compliance with applicable international regulations and standards (e.g., FDA, EU MDR, ISO 13485). This role involves the preparation and maintenance of regulatory submissions, interaction with regulatory bodies, and support for product development, quality systems, and post-market compliance. The Regulatory Affairs Manager plays a critical role in enabling global market access while mitigating regulatory risks and ensuring the safe and effective use of medical devices. Duties/Responsibilities: 1. Regulatory Strategy & Planning · Develop and implement regulatory strategies to support new product development, product changes, and international market expansion. · Interpret and communicate regulatory requirements to internal stakeholders to ensure proactive compliance from early development stages. 2. Regulatory Submissions & Approvals · Prepare, review, and submit regulatory submissions including: · FDA 510(k) · EU Technical Documentation (MDR Annex II & III) · CE Marking via Notified Bodies · Regulatory dossiers for Middle East, Asia, Africa, LATAM, etc. · Ensure timely approval of products and respond effectively to questions or deficiencies raised by regulatory authorities. 3. Product Development Support · Participate in design control processes, providing regulatory guidance during concept, development, verification, validation, and launch phases. · Define regulatory requirements for product labeling, claims, testing, biocompatibility, and clinical evaluations. · Ensure risk management (ISO 14971) and usability engineering (IEC 62366) are integrated into development processes. 4. Compliance & Quality System Support · Ensu

Sector: Medical Devices – Non-Sterile (External Fixators, Plates & Screws); Sterile (Hip Systems, Knee Systems, Nails, Screws) Duties/Responsibilities: o Develop and maintain comprehensive QC programs for orthopedic implant production, including inspection and testing procedures based on specifications, drawings, and standards. o Ensure compliance with global quality and regulatory standards (ISO 13485, EU MDD, etc.). o Oversee calibration and maintenance of QC tools, gauges, and equipment. o Supervise incoming, in-process, and final product inspection activities to ensure conformity with critical specifications. o Develop and validate inspection methods, sampling plans, and work instructions. o Lead and develop a team of QC inspectors and technicians. o Train QC staff on procedures, inspection techniques, documentation practices, and product knowledge specific to orthopedic implants. o Lead investigations into nonconforming products (NCRs), root cause analysis, and coordinate corrective/preventive actions (CAPA). o Work closely with manufacturing and QA teams to eliminate recurring defects and drive quality improvements. o Ensure accurate and complete recording of inspection results, traceability data, material certifications, and QC logs. o Maintain product quality documentation in alignment with DHR (Device History Record) and DMR (Device Master Record) requirements. o Support internal audits and regulatory inspections (Notified Bodies) by ensuring readiness and documentation accuracy. o Act as the QC lead during audits, providing objective evidence of compliance and driving closure of findings. o Identify trends in quality data (e.g., defect rates, rework, scrap) and drive initiatives to reduce variation and improve product consistency.

Sector: Medical Devices – Non-Sterile (External Fixators, Plates & Screws); Sterile (Hip Systems, Knee Systems, Nails, Screws) Job description: The Quality Control (QC) Manager – Orthopedic Implants is responsible for establishing, implementing, and managing quality control systems and inspection processes to ensure all orthopedic products meet defined specifications, regulatory requirements, and customer expectations. This role oversees in-process and final inspections, manages nonconformance investigations, and ensures that orthopedic implants—such as trauma plates, bone screws, Ilizarov systems, femoral and tibial nails, total knee systems, dynamic hip screws, and total or partial hip replacements—comply with international standards (e.g., ISO 13485, EU MDD). The QC Manager plays a critical role in maintaining product safety, functional performance, and full traceability throughout the manufacturing lifecycle. Duties/Responsibilities: · Develop and maintain comprehensive QC programs for orthopedic implant production, including inspection and testing procedures based on specifications, drawings, and standards. · Ensure compliance with global quality and regulatory standards (ISO 13485, EU MDD, etc.). · Oversee calibration and maintenance of QC tools, gauges, and equipment. · Supervise incoming, in-process, and final product inspection activities to ensure conformity with critical specifications. · Develop and validate inspection methods, sampling plans, and work instructions. · Lead and develop a team of QC inspectors and technicians. · Train QC staff on procedures, inspection techniques, documentation practices, and product knowledge specific to orthopedic implants. · Lead investigations into nonconforming products (NCRs), root cause analysis, and coordinate corrective/preventive actions (CAPA). · Work closely with manufacturing and QA teams to eliminate recurring defects and drive quality improvements. · Ensure accurate and complete recording of inspection res

Sector: Medical Devices – Hemodialysis Catheters (Short & Long Term), Peritoneal Dialysis Catheters, Urology Catheters, Central Venous Catheters, Sheath Introducers, and Accessories

Sector: Medical Devices – Hemodialysis Catheters (Short & Long Term), Peritoneal Dialysis Catheters, Urology Catheters, Central Venous Catheters, Sheath Introducers, and Accessories

Sector: Medical Devices – Hemodialysis Catheters (Short & Long Term), Peritoneal Dialysis Catheters, Urology Catheters, Central Venous Catheters, Sheath Introducers, and Accessories

Sector: Medical Devices – Hemodialysis Catheters (Short & Long Term), Peritoneal Dialysis Catheters, Urology Catheters, Central Venous Catheters, Sheath Introducers, and Accessories