ISO 9001 • ISO 13485 • ISO 14971 • MDR • TF / DMR / DHF • V&V • CAPA • Supplier Audits • Regulatory Submissions
Hands-on support for companies that require regulatory QMS execution, practical preparation and leading of audits, and performing submissions.
Highly motivated and results-oriented Medical Device Regulatory Specialist with over 19 years of experience ensuring compliance with international regulatory standards, including ISO 13485, ISO 9001 ,IPC 610 , CE Marking, MDR, IVDR, FDA, AMAR and Asian countries regulations.
Expert for products and companies primarily related to medical devices, electronics and pharma industries.
Proven ability to manage the regulatory lifecycle of medical devices, from development to market launch.
Skilled in technical writing, project management, and cross-functional collaboration.
Lead Auditor for MDR, MDSAP (from NB), ISO 13485 and ISO 9001 (from SII and IQC).
Interacting with regulatory bodies requires, careful planning and execution.
I’m an experts, with extensive regulatory experience, understanding the expectations and required documentation.
I’m providing guidance and support during submissions to CE, EU REP, Asia countries , MOH etc. to facilitate efficient and successful outcomes.
As a QA/RA consultant, I will lead you through the guidelines relevant to your
proposed indication and mechanism of action. I’ll ensure your submission
meets all regulatory requirements and contains the necessary components.
I’ll work closely with you, providing support until you achieve the desired
result and certification.
I’ll assist you in implementing effective risk management practices in
accordance with applicable standards such as ISO 14971. This includes
developing a Risk Management Plan, conducting thorough Risk Analysis,
and utilizing tools like pFMEA to identify and mitigate risks within your
facility, processes, systems, and equipment.
I’m a certified Lead Auditor , and can evaluate the readiness of a company and the robustness of your quality system, prior to any external audit, Including recognizing the gaps and offering the improvement program.
I’m providing a wide range of internal, external and site audits.
These audits are a necessary quality tool to meet RA requirements,
authorize suppliers, as well as to prepare for audits from the regulatory
authorities such as FDA, Notified Body, SII , MOH and more.
I provide support and lead all development
process from the aspect of quality and regulatory requirements.
I’ll help you establish effective processes for design control, ensuring
that your product meets the necessary quality and regulatory
requirements including: design reviews and planning of product
realization , review and support in creating product technical file , DMR and DHF.
I provide support in writing and reviewing validation & verification protocols and reports, IQ/OQ/PQ for safety, efficacy, and conformance to regulatory standards of the product V&V activities.
I assist in analyzing process capability, ensuring a smooth transition and maintaining consistent quality, throughout the manufacturing phase, which includes: Quality planning and execution of transfer to production and process capability analysis.
I help to maintain suppliers’ compliance by executing audit to your critical suppliers in the relevant field. Support in annually suppliers evaluation.
My services extend to non-conforming product management, complaint handling, and Corrective & Preventive Action (CAPA) support including effectiveness.
For any inquiries and questions please contact me directly by email, phone or LinkedIn.
Customer recommendations can be provided on demand.
