• Develop and deliver comprehensive lectures and conduct research on topics related to medical devices and regulatory compliance• Design and revise course curricula to ensure they meet the latest industry standards and regulatory guidelines• Guide and mentor students on their academic journey and career paths within the medical devices field• Conduct research and disseminate findings through publications in peer-reviewed journals focused on medical devices and regulatory affairs• Partner with industry professionals to offer students hands-on experience and insights into real-world regulatory challenges• Engage in departmental activities, including meetings and curriculum planning, to enhance academic offerings and strategies• Keep up with the evolving trends and regulations in the medical device industry and incorporate this knowledge into educational practices

•Formulating effective campaign strategies by analyzing political landscapes, voter demographics, and public sentiment to craft messages and policies that resonate with target audiences•Designing and delivering compelling messages and preparing articles through advertisements, social media, and public relations to shape public opinion and support for the candidate•Conducting surveys, focus groups, and statistical analyses to gauge voter behavior, preferences, and trends, providing actionable insights to refine strategies and policies

•Identify client issues and develop alternative strategies for presentation to client consultingwith other resources within the organization as required• Active member of the cross-functional project teams to lead regulatory discussions, includingthe development and execution of strategies for pipeline products to optimizeand accelerate launch excellence• Liaise proactively and work collaboratively with global, regional, and local colleagues inthe management of applications throughout the submission and evaluation processes toensure a high-quality and timely outcome• Evaluating the regulatory environment and contributing to providing internal advice throughoutthe product lifecycle (e.g., concept, development, manufacturing, marketing) to ensureproduct compliance• Verify for the general safety and performance requirement (GSPR), technical file, labeling,instruction for use (IFU), and unique device identification (UDI) system for medicaldevices comply with European Union Medical Device Regulations (EU-MDR) regulationParticipating in all phases of new product development and sustaining engineering tounderstand design intent, intended uses, and relevant regulatory standards• Planning, creating, and executing verification protocols, and reports, analyzing and summarizingresults, enabling formal design verification reviews, and owning the verificationand validation of the medical devices• Helping in the filing and signing of quality documents including quality manuals, standardoperating procedures (SOPs), work instructions, and related formats• Managing the review and approval process of clinical submissions documents, writingdocuments, generating consensus among reviewers, and facilitating discussions• Developing specific objectives and manage work assignments, with minimal guidance toachieve personal objectives in conformance with overall business goals

Plan, coordinate, and prepare document packages for regulatory submissions and renewalsrelating to different types of medical devices with emphasis on US 510(k) submissions,EU Technical File to Notified Bodies, and rest of the world (RoW) submissionswith the local affiliates• Perform Medical Device Regulations (MDR) gap assessments and remediation of MedicalDevice Directives (MDD) Technical Files• Analyze the adequacy of proposed regulatory pathways and strategy for initial productdesigns and recommend changes or refinements based on initial regulatory outcomes• Collaborate with business unit and international regulatory affairs personnel to supportmarketing authorizations for assigned projects• Author and/or review regulatory procedures and update as necessary• Review change control documents and ascertain regulatory impact for external and internaldocuments through formal regulatory assessments• Assist in the development/maintenance of regulatory files, records, and reporting systemsof systematic retrieval of information• Develop and manage programs that train stakeholders on current and new regulatoryrequirements to ensure organization-wide compliance• Communicate and interface directly with designated authorities and in-country distributorsto ensure timely registration approvals• Determining applicable testing requirements and standards for different medical devices• Monitoring the progress of the regulatory authority review process through appropriatecommunications with the agency• Identify and interpret laws, regulations, and guidance documents for domestic and internationalagencies relevant to the development and commercialization of healthcareproducts

-Research, Teaching, and Training Contributing to teaching and research including serving as a teacher, role model, and mentoring students, participate in the development and direction of research and educational program at the department level Complete evaluations for students and peers Applying the role of inter-disciplinary strategies combining engineering and biology to solve complex biomedical problems -Scholarly Activity Demonstrate effectiveness in securing grant funding of research initiatives and programs mentors and assist other faculty in grantsmanship Establishing an on-going commitment to and participating in scholarly activities at an advanced level as evidenced by publication of original research investigation, educational research, clinical observations, reviews, chapters, and books Applying innovative training in research methods to design and conduct clinical research on various areas of clinical specialty Fostering industry and clinical partnerships in healthcare needs Participate in collaborative research projects through interactions with researchers as well as individuals from other divisions & departments -Service and Administration Lead the integration of existing programs and development & growth of a major initiative of the assigned department and program Substantial leadership role in the direction of an academic division Participate as a member of the leadership team in developing consensus in the various programs, approaches, issues & new initiatives within the department

-Formulation of clinical protocols, methodologies and related documentation in collaboration with the multidisciplinary team including engineers and clinical doctors-Identify sites and manage study set-up-Support the study-related questions and serve as the point of contact for managing/ answering questions relating to trial procedures and subjects eligibility

Teaching courses in Fundamentals of Electrical and Electronics Engineering and BiomedicalInstrumentationDisseminate and impart basic or applied knowledge to studentsAssist students with the learning process and applying the knowledge

Research in biomedical optics, with emphasis on clinical applications of optical spectroscopyand label-free tissue sensing in general To form close collaborations with clinicians, research centers and companies to acceleratebiomedical optical technology and rapidly deliver this new technology into the handsof health-care providersUsing photonics as a driver for the faster development and deployment of more accurate,minimally invasive diagnostic and treatment methods for cancer and other disease types

- Design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities as per ISO 13485:2016 and risk management assessment for medical devices as per ISO 14971:2012- Verify for the general safety and performance requirement (GSPR), technical file, labeling, instruction for use (IFU), Unique Device Identification (UDI) system for medical devices comply as per new European Union Medical Device Regulations (EU-MDR) regulation- Evaluate and summarize clinical evidence including data from sources such as clinical investigations, scientific literature search, post-market surveillance (PMS), and post-market clinical follow-up (PMCF)- Research on requirements (local, national, international), applicable guidance and standards and options for regulatory submissions, approval pathways, and compliance activities- Collect and organize information on requirements for regulatory, quality, pre-clinical, and clinical data to meet applicable regulations- Key role in external and internal audits related to the product submission and notified body audit- Review and recommend changes for labeling, and clinical protocols to maintain regulatory compliance- Lead team to drive medical device product development for optical diagnosis of tumors and other areas of focus as applicable- Working in a cross-functional team of medical doctors, scientists, and engineers in addressing clinical problems and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from a global and/or regional perspective

- Creating, reviewing, and updating technical documentation, product description, instruction for use (IFU), design and manufacturing information- Proven track record in building and managing a dynamic and high-performance medical writing team that is fit-for-purpose and resource-efficient- Responsible to plan, coordinate and conduct the execution of design protocols (eg. design validation and verification), testing reports, specifications, device master record (DMR), and design history file (DHF) updates- Generate test protocols, analyze test data, and generate written reports- Verification and validation activities for new/replacement and existing products and components- Review of adequacy of product specification and support regulatory-related remediation that involves product design or functionality.- Utilize technical data and statistical analysis techniques such as measurement system analysis, process capability studies, and design of experiments (DoE)- Capability to interpret design and development related documents, functional and performance testing, biocompatibility, and risk analysis concerning safety regulations, quality policies, best practices, and procedures through training

- Develop and translate an investigational device based on Trimodal spectroscopy for detecting brain tumor margins. This instrument was to be installed in the Department of Neurosurgery at the Anna Meyer Pediatric Hospital to conduct active clinical studies- Establish an investigational review board (IRB) to evaluate and monitor biomedical research involving human subjects for submission to the local regulatory authorities including the Department of Planning and Organization of the National Health Service, Italy, Food and Drug Administration (FDA) as a part of Code of Federal Regulations (CFR)- Support deployment of the quality management system (QMS) structure to ensure compliance to ISO 13485, 21 CFR 820, and European Regulations- Maintain, enforce, and manage compliant and effective QMS for the activities in scope, as well as for effective and lean QMS structures and documents for quality and regulatory (Q&R) processes at all levels- Report on key performance indicators (KPIs) to adhere to process and prevent the occurrence of any non-conformity relating to product, process, or system and data analysis using various statistical tools- Help in the filing and signing of quality documents including quality manuals, standard operating procedures (SOPs), work instructions, and related formats- Manage the review and approval process of clinical submissions documents, writing documents, generating consensus among reviewers, and facilitating discussions- Tracking medical device-related information utilizing databases, spreadsheets, and other tools

- Applied diffuse reflectance spectroscopy for monitoring the wound healing process in diabetic foot ulcers and the effects of probe pressure on spectroscopic measurements- Literature search, analysis, and summarization of the relevant clinical data- Participate as the clinical representative for review and summarize of post-marketing surveillance data and risk analysis activity, complaint investigation- Collaborate with the project/program stakeholders for product knowledge and information to develop quality content for the CER and within the required timelines- Understand clinical data from literature and clinical trials to ascertain safety and performance outcomes relevant to the device under evaluation

Worked on various projects related to liquid crystals, imaging through turbid medium,surface plasmon resonance

Performed experiments for the differentiation of normal and malignant oral tissues usingfluorescence, diffuse reflectance and synchronous luminescence spectroscopy.Identifying sensitivity and specificity diagnosis criteria for normal and malignant oraltissues.Development of physical tissue models for spectroscopic applications

Collaborating with surgeons and pathologists for minimally invasive diagnosis of oralcancerLearnt various aspects of tissue pathology

Interact with customers to provide and process information in response to technical inquiries,concerns, and requests about products and services related to palm-One handheldsFollow standard processes and proceduresIdentify and escalate priority issues per client specificationsRedirect problems to appropriate resource