Gurunathan M Email & Phone Number

Bangalore

Bangalore

1. Building quality culture across Commercial Organization.2. Ensuring compliance to quality & regulatory requirements3. Implementing Global quality procedures & global work instructions. Creating procedures, work instructions, flow charts and power-point slides into processes to meet local regulatory requirement 4. Educate, train, advise & coach company professionals & customers to ensure compliance with RA requirements.5. Timely execution & maintenance of regulatory approvals for products sold in South Asia6. Influencing & relation building with regulators 7. Creating environment friendly for manufacturing, distributions & services of medical devices by interacting with Regulators & Trade associations.8. Driving improvements in defined metrics impacting customer &/or business such as recalls, training & effective CAPA closures.9. Identifying & reporting any quality or compliance concerns with management & take immediate corrective action as required.10. Guiding & reviewing marketing materials in compliance with regulatory requirement11. Analyze & communicate proposed, new or changing requirements & standards12. Leading teams to develop strategies, programs and processes to meet business objectives & ensure compliance with regulatory requirements. 13. Communicating with regulatory authorities within areas of responsibility. 14. Work across organization to ensure a consistent approach to regulations is adopted throughout the business within areas of responsibility15. Identify global regulatory trends & their implications for organization, taking into consideration impact on business decisions16. Lead & support continuous improvement activities with regards to areas of responsibility.

Bangalore, India

1. Building quality culture across Commercial Organization.2. Ensuring compliance to quality & regulatory requirements3. Implementing Global quality procedures & global work instructions. Creating procedures, work instructions, flow charts and power-point slides into processes to meet local regulatory requirement 4. Educate, train, advise & coach company professionals & customers to ensure compliance with RA requirements.5. Timely execution & maintenance of regulatory approvals for products sold in South Asia6. Influencing & relation building with regulators 7. Creating environment friendly for manufacturing, distributions & services of medical devices by interacting with Regulators & Trade associations.8. Driving improvements in defined metrics impacting customer &/or business such as recalls, training & effective CAPA closures.9. Identifying & reporting any quality or compliance concerns with management & take immediate corrective action as required.10. Guiding & reviewing marketing materials in compliance with regulatory requirement11. Analyze & communicate proposed, new or changing requirements & standards12. Leading teams to develop strategies, programs and processes to meet business objectives & ensure compliance with regulatory requirements. 13. Communicating with regulatory authorities within areas of responsibility. 14. Work across organization to ensure a consistent approach to regulations is adopted throughout the business within areas of responsibility15. Identify global regulatory trends & their implications for organization, taking into consideration impact on business decisions16. Lead & support continuous improvement activities with regards to areas of responsibility.

Bengaluru Area, India

Regulatory Affairs Leader for Ultrasound & Life Support Solution Systems1. Developed a project strategy to ensure that the registration needs of various countries were met, risks were minimized, and domestic and international product-submit processes were streamlined2. Design review in every stage of product development3. Generated regulatory documents including Technical Files, Declarations of Conformity, Certificates to Foreign Government, and Certificates of Origin used for global product registration4. Partnered with global and regional marketing teams to develop regulatory and global registration plans5. Documented and maintained oral and written communications with global regulatory agencies6. Assisted in the development and maintenance of regulatory files, records, and reporting systems

Bengaluru Area, India

Regulatory Affairs Specialist for Ultrasound & Life Support Solution Systems.

Bengaluru Area, India

Safety & Regulatory Affairs Leader for Ultrasound Engineering.1. Interacting with NRTL for getting product safety and EMI/EMC certificates 2. Product regulatory submission for Market such as FDA, KFDA, MHLW, SFDA & etc.3. Providing the safety and regulatory requirements for product design4. Design review in every stage of product development5. Trouble shooting and providing solution on Product safety or EMI/EMC issues 6. Performing Acoustic power measurement for the Ultrasound transducer as per IEC60601-2-37 & AIUM/NEMA Standards.7. Involvement in the internal quality management system audits.

Bengaluru Area, India

Production & Process control for Ultrasound Manufacturing Line.

Bengaluru Area, India

Design and Development of embedded system. Prototyping & testing integrated system for boundary conditions. Writing test routine software.