Kalyan Kumar Gopal

Fostered a culture of continuous improvement by encouraging staff to share innovative ideas and providing resources for professional development.

• Prioritized tasks and allocated resources appropriately to keep teams focused and productive.
• Assisted senior leadership in managing all aspects of operations.
• Managed cross-functional teams for multiple large-scale projects, successfully completing each on time and within budget constraints.
• Trained and developed department leaders and management staff for specific projects and ongoing operational needs.
• Mentored junior staff members, providing guidance on professional development opportunities and career progression paths within the company.
• Reviewed proposed regulatory changes and evaluated potential impacts on business operations.
• Supported capital project planning and contributed to feasibility studies.
• Provided strategic analysis for manufacturing life cycles, technologies, process validations, and robustness.

• Identifies issues to be addressed and areas of concern where IVDR may hinder the registration
• Prepares and communicates IVDR project-related documentation
• Successfully lead a team of cross functional team of subject matter authorities in a highly matrixed organization
• Leads teams that are necessary to complete required changes including: systems support and development, labeling, processes for product in the EU, supports efforts to manage Economic Operators and other duties
• Participates and coordinate with CFT to ensure compliance with the quality system
• Ability to lead multiple projects concurrently
• Effective and frequent communication of status of project status to all levels of the organization
• Monitors and interprets IVDR regulations and guidelines and interacts with project teams to provide guidance to complete deliverables per established deadlines
• Works closely with Program director on all matters to assure consistency and alignment between third party and Regulatory departments of BD
• Participates in the development, review or approval for notified body Submission
• Reviews and/or audits data related to regulatory projects and functions
• Carries out duties in compliance with established business policies
• Collaborates well with others building effective working relationships; negotiates to build broad-based support and/or persuades others to influence meaningful outcomes.

• Coordinate in performing sterilization and bio-compatibility studies (ISO:10993)
• Perform polymer material selection for the medical device based on the clinical compatibility and by understanding the manufacturing method of the materials
• Design, plan and conduct clinical research trials by effectively coordinating the activities of study coordinators and investigators and by ensuring compliance with study protocols, GLP, GCP, FDA and International regulations, IRB and/or Ethics committees' requirements and overall clinical objectives
• Co-ordinate in performing pre-clinical studies, animal study with approval from CPCSEA and IAEC
• Obtain approval from regulatory boards for conducting clinical trial
• Attend relevant scientific and/or medical meetings
• Includes 30 to 50% travel
• Develop and implement strategies for the earliest possible approval of regulatory submission.

• Responsible for Pharmacological, molecular and cellular models for NCES
• Actively involved in establishing NCE for Oncology and Inflammation (OCID 2287/5005)
• Toxicological studies
• Worked and Achieved GLP/AAALAC Certification as a Team member
• Design, conduct and monitoring of Preclinical studies for Pharmaceuticals, IVD, Medical devices and Cosmetics
• Preparation and peer review reports for GLP compliance as per OECD, EPA, and ICH guidelines
• Implementation of new testing models for toxicology studies
• Regular communication with clients, hosting client visits and inspections
• Facilitate collaboration with academic centers as necessary to complete investigative studies.

• Involving disease diagnosis testing methods in hematology, clinical chemistry, and endocrinology
• Analysis of hematological parameters such as complete blood picture, blood gas and electrolyte analysis
• Tools and Technology used: CLSI standards / Microbiology Guidelines/ Instruments

• Perform laboratory testing (Blood culture, AST, Mycobacterium culture analysis)
• Coordinate with other department histopathology and cytology department and perform routine activity