development of the implemented GMP system to meet the FDA requirements for drug delivery device

registration activities for medical devices all over the word implementation and maintenance QMS MDD transformation into MDR for system and product

Regulatory and Quality Assurance professional with almost 20 years' experience in the Medical Device industry, with an emphasis on FDA and EU regulations and guidelines.Expertise includes development, implementation, and management of Quality Management Systems (QMS), Standard Operating Procedures (SOPs), document and records management, validation and training programs. Current scope of the activities • planning, maintaining and executing strategic application and registration for a medical device worldwide • regulatory and quality support for implementation of new products • gab analysis and implementation and transformation from MDD into MDR for all medical devices available into portfolio • managing the clinical experts department • biological risk assessment for medical devices • managing the quality system based on ISO 13485 standard , GMP and MDSAP • managing the quality control department

•Implementation and maintenance of the Quality Management System as per the requirements binding for medical device manufacturers: ISO 13485, CAN ISO 13485, FDA CFR 21, part 820 and the Japanese J-Pal.•Representing the Companies before the Notified Body with regard to external and customers’ audits. •Ensuring compliance of the manufactured medical devices as per the requirements of MDD, FDA; •registration of medical devices worldwide (China , Brazil, Mexico, Australia, Japan, Korea)•510k application experience with clearance from FDA•Planning and control over the audit schedule at the company and at the suppliers’. Selection and control over the team of auditors. •Registration, control over and evaluation of CAPA actions undertaken in the Company. •Handling customer complaints; medical device incident reporting as per the valid regulations for medical devices on all markets. •Gathering and control over the Technical Files for medical devices, control over the design and system documentation of the company, developing system documents, SOPs, the Quality Manual. •Conducting training in the requirements for medical devices. •Participation in new projects – development of new medical devices; participation in health hazard evaluation, risk analysis and process validations. •Bioconformity assessment for compliance with the requirements of ISO 10993. •Control over the sterilization process of the manufactured medical devices; validation of the•Supervising of department for design and labeling for medical devices

-maintains, develops and changes the Quality Management System as per the requirements of standard ISO 13485, Medical Device Directive, Polish regulations for medical devices, FDA CFR 21 Part 820 and J-PAL,-acts as the Management Representative as per the requirements of ISO 13485, CFR 21 part 820.20, and the Engineering Manager as per J-PAL, Ordinance 169, -updates and coordinates the process of monitoring of knowledge related to international medical device regulations, -medical device registrations all over the word-controls the customer complaint process, -develops the risk management strategy for the medical devices -project managment proces control -within implementation of new products and market and product expansion, control the process of packaging design and medical device labeling projects

•Implementation and maintenance of the Quality Management System as per the requirements binding for medical device manufacturers: ISO 13485, CAN ISO 13485, FDA CFR 21, part 820 and the Japanese J-Pal.•Representing the Companies before the Notified Body with regard to external and customers’ audits. •Ensuring compliance of the manufactured medical devices as per the requirements of MDD, FDA; registration of medical devices worldwide. •Planning and control over the audit schedule at the company and at the suppliers’. Selection and control over the team of auditors. •Registration, control over and evaluation of CAPA actions undertaken in the Company. •Handling customer complaints; medical device incident reporting as per the valid regulations for medical devices on all markets. •Gathering and control over the Technical Files for medical devices, control over the design and system documentation of the company, developing system documents, SOPs, the Quality Manual. •Conducting training in the requirements for medical devices. •Participation in new projects – development of new medical devices; participation in health hazard evaluation, risk analysis and process validations. •Bioconformity assessment for compliance with the requirements of ISO 10993. •Control over the sterilization process of the manufactured medical devices; validation of the

•Ensuring the required operation and performance of the laboratory. •In charge of 12 employees, organization of their work, designating tasks and control over quality testing of a wide range of construction products as per the binding procedures and SOPs based on standard ISO 9001. •Keeping records, control over testing documentation and laboratory equipment. •Performing tests and keeping records related to customer complaints. •Maintaining contacts and cooperation with key departments of the company: production, domestic and foreign purchasing, sales.