Nishanth Reddy Deva Email & Phone Number

Greater Pittsburgh Region

Pittsburgh, Pennsylvania

Pittsburgh, Pennsylvania

•Assist with the planning and preparation of international product approval submissions for the approved Class I and II radiological medical devices.• Implement regulatory strategies through coordination and preparation of submission documents for the registration of new products and changes to existing products in international markets (i.e. LATAM, Europe, MEA, Asia pacific).• Collaborate with the other RA functions (e.g. Regional RA, RA product strategist) regarding regulatory submissions and timelines.• Maintains ongoing surveillance and analysis of all pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems• Reviews device labeling and marketing materials for compliance with International submissions and applicable regulations• Prepare RSoC (Regulatory statement of conformity) to certify that Bayer products have been evaluated and met all applicable safety and regulatory requirements to be marketed and put into service at the final customer site in the listed countries.• Provide applicable documents for international supply submissions.• Communicate with manufacturers, requesting additional information.• Supports the product release process by writing the PRA forms and ensuring that they are released through GTS or reviewing and approving requests for product release.• Conducts reviews of product and manufacturing changes for compliance with applicable regulations - Reviews protocols and reports to support regulatory submissions• Contribute to the Global Regulatory Affairs team by providing project-based updates and action plans as needed. Serve as a regulatory contact for specific projects and /or program related activities.

Virginia, United States

• Assisted with the planning and preparation of 510(K) and International submissions• Provided Post-Market Surveillance support for the approved Class II and III orthopedic medicaldevices• Evaluated key issues for USFDA inspection and with Health Authority experts to clarifyquestions• Reviewed and edited Quality Management System policies and procedures, and design historyfiles for clarity, accuracy and compliance with US, Canadian and European regulations as well asISO 13485, ISO 14971 and IEC 62304 standards• Reviewed customer complaints for safety issues; non-conformances and CAPAs for effectiveness• Supported regulatory compliance activities for post market vigilance reporting (MDR), productrecalls• Participated in documenting the EU Technical Files to obtain CE marking activities• Prepared compliance reports as per 21 CFR 820; conducted risk assessment as per ISO 14971

Hyderabad Area, India

• Conducted tests; ensured compliance to codes; followed manufacturer’s instructions; troubleshooting and repairing; calling for special service; maintained equipment inventories; completedtest records; equipment sterilization• Maintained biomedical equipment (establishing, adjusting, calibrating, testing)• Prepared and delivered technical presentations explaining products or services to customers andprospective customers.• Maintained client/patient/company confidentiality; HIPAA compliance• Conferred with customers and engineers to assess equipment needs and to determine systemrequirements.• Involved in adjusting; calibrating; testing and documenting equipment performance• Writing, reviewing and executing test procedures; documenting test results (records)• Trained clinicians and other personnel on the proper use of equipment.• Evaluated the safety, efficiency, and effectiveness of biomedical equipment.

Hyderabad Area, India

• Repaired, Maintained and provided technical support of Gamma camera and PET-CT.• Prepared and presented report for health professionals.• 21 CFR 820, ISO 14971, ISO 13485.• Trained clinicians on proper usage of the equipment.• Maintained biomedical equipment supplies inventory, anticipating needs; maintaining orders.• Maintained a safe and organized production/ test lab.

Master'S Degree, Biomedical/Medical Engineering, 3.33/4.0

Activities and Societies: Volleyball player for Chemical & Biomedical Engineering department.MASTER's degree from Cleveland State.

Bachelor'S Degree, Biomedical/Medical Engineering, 3.6/4.0

Activities and Societies: • Convenor of Meditech-2k13, the national level technical symposium organized by Department of Biomedical.