Sachin Dhiman

• Building up strong advocacy and liaising with external bodies, such as different government authorities, industry forums, tender authorities, and business leaderships.
• Shaping the guidelines, regulations, with industry forums. Active participation in conclaves, conferences, and meetings organized by industry forums.
• Active Handling regulatory-related operations of India, Sri Lanka, Bangladesh, and Nepal.
• Regulatory support in terms of the establishment of a third-party manufacturing facility in India. Preparation of documentation for participation in tender and trade business.
• Establish and maintain the necessary technical documentation for the (Endoscopy) product registration in India.
• Making an endorsement application, loan license registration, new product registration, and renewal application on the Sugam Portal CDSCO.
• Liaison with external and internal stakeholders of Richard Headquarters and the India region on all registration application-related concerns.
• Harmonization and preparing the labels according to the Indian MDR, Drug and Cosmetics Act, Legal Metrology, etc.
• Support the MDD to MDR transition, and conduct a gap analysis during the transition period. File post-approval changes (PAC) in the authority according to the respective classification mentioned in the MDR.
• Analysis of national and international legal requirements according to the medical device association’s work in the field of medical devices in India.
• Managing the commercial-related aspects, such as the execution of distributor agreements, warehouse compliance, logistics activities, etc.
• Active participation in internal processes and the development of new products and technology.
• Partner with the project team to ensure the approval at each review gate.
• Ensuring personal and company compliance with local regulations, policies, and procedures.
• Establishing and maintaining quality as required.

Quality Domain -

• Alignment of the warehouse according to QMS standards. Attending internal and external audits. Handling of documentation and good distribution practice.
• Maintenance of shipment - regulatory and quality check controls to be more efficient and compliant.
• Product complaint reporting management. Handling of quality notifications. CAPA management.
• Internal distributor audit management. Active regulatory compliance. Product recall management.

• Job Period: June 2023 to Present.
• Key Responsibilities:

• Preparation, review, and submission of different finished products, IVD, and medical devices dossiers according to CDSCO guidelines.
• Interaction with Indian regulatory bodies and industry forums such as state FDA, BIS, CDSCO, NIB, DoP, NPPA, FICCI, Legal Metrology, CII, etc.
• Management of regulatory operations of countries such as India, Sri Lanka, Bangladesh etc.
• Preparation and review of pharmaceutical products, medical device labels, according to the Medical Device Rule of 2018 and the Legal Meteorology Act.
• Handling of the gap analysis between IVDD and IVDR. Instruments and software submission according to GSR 102 guidelines.
• Maintenance of post-approval changes, testing license-related activities, classification of the post-approval variations, and submission to the authority within the stipulated period.
• Filing of test license, performance evaluation reports (PER), import license, etc.
• Keeping abreast of new guidance, notifications issued by the health authority, and sharing the feedback to make changes in the said documents.
• Quality Domain
• Handling of worldwide field safety corrective actions (FSCA) and adverse event (AE) data to prepare the PMS and PSUR data. Handling of product complaints, AE, quality and market notification, medical inquiries, approval of promotional materials, etc.
• Management of quality notifications, safety board notifications pertaining to different IVDs, and reporting to respective authorities in the stipulated period. Responding to queries and clarifications to authority on time.
• Distribution-related segments management (Qualification, Audit, distributor certifications, and standard and training).
• CAPA management and leading the team to prevent the potential causes of the bottlenecks.
• Handling of tender documentation-related activities and dealing with tender authorities for final execution and further processes.
• Job Period in Roche - December 2021 to May 2023
• Key Responsibilities-
• Supervised day-to-day operations to meet performance, quality and service expectations.

• Preparation and submission of Medical device product dossiers pertaining to different countries such as EU and India according to EU MDR, CDSCO (SUGAM) guidelines.
• Conduction of Usability study according to USDFDA 510 k process and filing the same inthe authority in a stipulated period.
• Preparation of questionnaire for usability study to be conducted on different population ofcountry.
• Actively participating in GAP analysis between MDD and MDR thereby identifying gaps inthe current devices.
• Performing of document analysis with the help of different software database Agile, MRCS, Enovia, Webtop etc.
• Performing of Input analysis of respective dossier according to MDR requirements and interaction with SME to fulfill the requirements.
• Performing the process for preparation of labels according to EUMDR requirements.
• Coordination with Geographical RA to meet the regulatory requirements and performing thegap analysis.
• Interaction with client on weekly and monthly basis to update the project status execution.
• Updating of different TATA and Client side tracker sheet and maintain the data of team.
• Preparation and represent of presentation to client related to different challenges and aspectsof tasks.
• Job Period in Tata Elxsi - June 2021 to Nov 2021
• Key Responsibilities –

• Preparation, review, and submission of different medical device product dossiers in the SUGAM portal of CDSCO and other authorities.
• Maintenance of different licenses and file renewal applications for getting the perpetual license from the authorities.
• Handling of tender documentation-related activities and dealing with tender authorities for final execution and further processes.
• Reporting of post-approval changes according to the respective classification, with required supportive data, according to the Medical Device Rule 2018.
• Preparation and review of medical device and their related accessories' labels according to the Medical Device Rule 2018 and the Legal Meteorology Act.
• Responsible for the preparation, review, and approval of promotional material, technical documentation, and research papers to be used in marketing.
• Handle meetings and interactions with the overseas team, domestic and international authorities, in order to execute the assigned practice on time.
• Execution of pricing-related practice/documentation and intermittent meetings with NPPA.
• Quality domain -
• Handling of PAN India product complaints of medical devices with the help of Q Track software database and identification of causality assessment.
• Responsible for conducting internal audits of different warehouses in order to ensure they comply with global quality standard parameters.
• Preparation and execution of standard operating procedures (SOPs) of regulatory, quality, and compliance.
• Handling pharmacovigilance-related activities, local literature survey, compilation, and submission of PSUR to the regulatory authority as a PVRP (PV responsible person).
• As a quality person responsible for conducting distributors' audits to make them align and regulated as per regulatory requirements.
• Respondent to take immediate action on Field Safety Corrective Action (FSCA) for different medical devices and related accessories.
• Handling of recall management, Good Distribution Practice (GDP) conditions.
• Abreast of FDA CFR Part 820, EU medical device regulations, and process structure.
• Preparation and alignment of medical device labels, PAN India warehouse activities according to the Legal Metrology Act.
• Job Period - December 2018 to April 2021
• Experience- ( 2 years 4 months)
• Key Responsibilities-

• Responsible for the preparation and review of medical device and blood product dossiers, application for renewal registration (Form 41) of different products, and import license (Form 10) for biological products according to CDSCO guidelines.
• Design and preparation of the label, SMPC, PIL, and align them according to the respective guidelines, and get them approved by different departments.
• Preparation of documents for customs clearance, NIB clearance, and dealing with said authorities for expedited clearance.
• Responsible for conducting internal audits of PAN India warehouses and aligning them according to GDP guidelines.
• Dealing with different therapeutic area physicians to understand the epidemiology and prevalence of disease before launching the product in the market.
• Preparation and collection of tender documents pertaining to different state authorities, and deal execution of tender bids according to respective criteria.
• Responsible for preparing post-approval variation dossiers according to CDSCO guidelines and submitting them within the stipulated period of time.
• Dealing with the sales team and training them for a different product range. Follow up on different product complaints, medical inquiries, adverse drug reactions, etc.
• Development and review of SOPs pertaining to product shipment, warehouse maintenance, supply chain, and product emergency recall notification according to GDP (Good Distribution Practice) CDSCO guidelines. Responsible for conducting an internal audit of quality maintenance in different supply chain and logistics activities.
• Pharmacovigilance literature survey to identify adverse events, side effect occurrences. Dealing with specific HCPs (health care professionals), reporters collect AE information for further processing in ARGUS software.
• Job Period - 1 October 2014 to December 2018 (4 year 2 months)
• Key Responsibilities-