JOB DESCRIPTION: SENIOR SALES EXECUTIVE-(DOMESTIC MARKET) About us Madhu Instruments Pvt. Ltd. (MIPL) manufactures high quality medical devices specializing in ophthalmology. Our commitment towards quality is paramount. With a proven track record of cutting-edge innovation and a reputation for adhering to the international best practices, quality compliance and reliability, we offer a myriad of ophthalmic devices to ensure best care for patients and hassle-free procedures for the doctors. Responsibilities: Giving valuable inputs to Sales and Marketing Manager in planning of a customized annual national sales strategy, including but not limited to distributors, doctors, hospitals, and institutions Identify competitive opportunities within the market and advice decisively to Sales and Marketing Manager ways to capitalize on opportunities on a continual basis Work with the Sales and Marketing Manager in preparing monthly forecasting, sales planning, and other initiatives demanding field and customers input. Regularly meet the distributors, doctors, hospitals and institutions Build rapport with distributors, doctors and purchase departments to gain the knowledge of rapid selling brands in the domain and any other useful feedback Review and support day to day activities of Executive-Sales Operation Responsible to set-up surveys with key customers leveraging their feedback for effective sales strategy and/or innovation Manage entire North Zone and allocated part of NCR Ensure effective planning of field travel Requirements: Currently in a sales management role for ophthalmologic medical devices Considerable experience working across geographical regions in India, with impressive sales growth record At least 3 years’ experience leading commercial activities in ophthalmic medical devices/ pharmaceutical industry with experience including, marketing plan development, selecting and managing distributors, and key account management Hand on experience on working on India Mart and other online marketing and sales portals Possess good leadership skills with ability to coach, motivate and impact people and results remotely Experience in managing multiple distributors is critical Excellent poise and confidence when interacting with physicians, hospital administrators, and sales staff Requires frequent travelling Qualification: Any Graduate Key Capabilities and Competencies: 1. Positive attitude 2. Goal focused 3. Effective leadership and team management skills 4. Proficient in MS office with excellent Excel and Ppt skills 5. Adaptive to technology updates, using CRMs, etc. 6. Excellent communication skills Show more Show less
The ideal candidate will be responsible for building and maintaining a strong sales pipeline. You will do so by identifying key business opportunities and segmented prospects. Your goal will be to meet or exceed our annual quota and increase our revenue. Responsibilities Giving valuable inputs to Sales and Marketing Manager in planning of a customized annual national sales strategy, including but not limited to distributors, doctors, hospitals, and institutions Identify competitive opportunities within the market and advice decisively to Sales and Marketing Manager ways to capitalize on opportunities on a continual basis Work with the Sales and Marketing Manager in preparing monthly forecasting, sales planning, and other initiatives demanding field and customers input. Regularly meet the distributors, doctors, hospitals and institutions Build rapport with distributors, doctors and purchase departments to gain the knowledge of rapid selling brands in the domain and any other useful feedback Review and support day to day activities of Executive-Sales Operation Responsible to set-up surveys with key customers leveraging their feedback for effective sales strategy and/or innovation Manage entire North Zone and allocated part of NCR Ensure effective planning of field travel Qualifications Currently in a sales management role for ophthalmologic medical devices Considerable experience working across geographical regions in India, with impressive sales growth record At least 3 years’ experience leading commercial activities in ophthalmic medical devices/ pharmaceutical industry with experience including, marketing plan development, selecting and managing distributors, and key account management Hand on experience on working on India Mart and other online marketing and sales portals Possess good leadership skills with ability to coach, motivate and impact people and results remotely Experience in managing multiple distributors is critical Excellent poise and confidence when interacting with physicians, hospital administrators, and sales staff Requires frequent travelling
About US Madhu Instruments Pvt. Ltd. (MIPL) manufactures high quality medical devices specializing in ophthalmology. Our commitment towards quality is paramount. With a proven track record of cutting-edge innovation and a reputation for adhering to the international best practices, quality compliance and reliability, we offer a myriad of ophthalmic devices to ensure best care for patients and hassle-free procedures for the doctors. Responsibilities Device Master File Compliance Draft the Device Master File to align with Indian Medical Device Rule 2017 requirements, ensuring full compliance for regulatory submissions and audits. Clinical Data Collection and Compilation Collect and compile data related to device safety and performance from scientific journals and databases, including EMBASE, PubMed, and Cochrane, to support regulatory submissions and product evaluations. Technical Documentation and Regulatory Compliance Assist in drafting technical documents, including Biological Evaluations, Risk Management, and Usability Reports, in compliance with EUMDR 2017/745 regulations. Prepare and manage technical files for certification audits to meet EUMDR 2017/745 standards, ensuring that all documentation is thorough and accurate. Quality Management System (QMS) Compliance Ensure thorough understanding and implementation of QMS standards as per ISO 13485:2016 and Annexure IX of EUMDR 2017/745. Maintain and update all QMS documentation, including manuals, procedures, and policies, to ensure ongoing compliance with quality standards. Quality Documentation Management Create, update, and manage company quality documentation, ensuring that manuals, procedures, and records are maintained accurately. Monitor and enforce consistent implementation of quality management systems across the organization. Audit Management Coordinate internal and external audits, including those conducted by notified bodies, focusing on QMS and CE marking. Address any non-conformance reports promptly and efficiently, working toward continuous improvement. Customer Complaint and Incident Management Qualifications Education: Bachelor’s degree in a relevant scientific or engineering field, preferably with a focus on medical devices. Experience: 2-5years in QA for medical device manufacturing, with in-depth knowledge of relevant regulations and standards. Technical Skills: Proficiency in regulatory requirements (Indian Medical Device Rule 2017, EUMDR 2017/745, ISO 13485:2016). Expertise in data sourcing from EMBASE, PubMed, and Cochrane, with strong data compilation skills for clinical evaluations. Soft Skills: Strong written and verbal communication skills. Excellent organizational skills and attention to detail.
Responsibilities 1. Conduct market research to identify selling possibilities and evaluate customer needs . 2. Maintain relationships with clients by providing solution to their queries, giving them correct information, recommending profit improvements. 3. Handle receipt, review and on time dispatch of orders to customers 4. Coordination with dealers to motivate them to increase their sales & understand their problems. 5. Maintain quality service by establishing and enforcing organization standards. 6. Prepare and deliver appropriate presentations on products to the clients. 7. Participate on behalf of the company in exhibitions and conferences. 8. Prepares reports by collecting, analyzing, and summarizing information. 9. Handling CRM. 10. Maintaining records of sales and customers. 11. To ensure proper control of logistics costs, inventory costs and freight costs as per budget. 12. Negotiate/close deals with clients. 13. Collaborate with other department teams to achieve individual and organizational goals. Requirements: Vast experience of handling international customers Knowledge of required export shipment documents Hands on experience on advanced Excel Knowledge of export sales Cycle and its basic requirements Knowledge of CRM systems usage Ability to build relationships with key stakeholders. Self-motivated and a proactive attitude Excellent communication skills, cross functional experience and strong interpersonal skills Team Player with positive attitude ready to work in a fast-paced environment Proficient in English language-speaking, writing & reading Qualifications Graduate/Post Graduate (Preferably with a management degree) Key Capabilities and Competencies: 1. Positive attitude 2. Goal focused 3. Effective leadership and team management skills 4. Proficient in MS office with excellent Excel and Ppt skills 5. Adaptive to technology updates, using CRMs, etc 6. Excellent communication skills
Company Description Madhu Instruments Pvt Ltd (MIPL) manufactures high quality medical devices specializing in ophthalmology. Our commitment towards quality is paramount. With a proven track record of cutting-edge innovation and a reputation for adhering to the international best practices, quality compliance and reliability, we offer a myriad of ophthalmic devices to ensure best care for patients and hassle-free procedures for the doctors. Role Description Create or update documents related to Preventive Maintenance and Building Maintenance. Keep the records updated related to Preventive Maintenance and Building Maintenance. Conduct and guide the maintenance team in conducting maintenance of equipment, machines and building infrastructure utilities. Conduct trainings of the team. Create or update SOPs (Standard Operating Procedure) related to Maintenance. Conduct follow-ups & oversee all maintenance related work. Qualifications Graduation degree or diploma in relevant field(s). Good knowledge of HVAC, electrical and mechanical systems. Proficiency with computer system especially MS Word and MS Excel. Problem solving attitude. Proficiency in English language. Ability to work independently. Team-oriented personality. 4-5 years of experience in a maintenance role, with at least 2 years in a supervisory position.
You will be responsible for creating or updating documents related to Preventive Maintenance and Building Maintenance. It is essential to keep the records up-to-date concerning Preventive Maintenance and Building Maintenance. Your role will involve guiding the maintenance team in conducting maintenance of equipment, machines, and building infrastructure utilities. You will also be required to conduct trainings for the team and create or update SOPs (Standard Operating Procedure) related to Maintenance. Additionally, conducting follow-ups and overseeing all maintenance-related work will be part of your responsibilities. To excel in this role, you should have a Graduation degree or diploma in relevant field(s) along with good knowledge of HVAC, electrical, and mechanical systems. Proficiency with computer systems, especially MS Word and MS Excel, is necessary. A problem-solving attitude, proficiency in the English language, ability to work independently, and a team-oriented personality are also essential qualities. The ideal candidate should have 4-5 years of experience in a maintenance role, with at least 2 years in a supervisory position.,
JOB DESCRIPTION: EXECUTIVE ASSISTANT Responsibilities Manage and maintain the Director’s calendar, including scheduling meetings, appointments, and travel arrangements. Act as the first point of contact for internal and external communications on behalf of the Director. Prepare and edit correspondence, reports, presentations, and other documents as needed. Coordinate and support meetings, including preparing agendas, taking minutes, and following up on action items. Maintain confidential and sensitive information with the utmost integrity. Liaise with internal departments and external stakeholders to ensure seamless communication. Assist in preparing for meetings, conferences, and events. Manage special projects and conduct research as directed by the Director. Organize and maintain physical filing systems. Be prepared to handle daily unforeseen tasks and challenges. Qualifications Proven experience (3+ years) as an executive assistant or in a similar administrative role. Exceptional organizational and time-management skills. Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and virtual communication platforms (Zoom, MS Teams). Ability to work independently with minimal supervision and adapt to changing priorities. High level of discretion and professionalism. Strong problem-solving abilities and attention to detail. Proficient in English language -Verbal and written. Qualification Bachelor’s degree preferred; additional qualifications in Office Administration are a plus. Salary-35k-40k (CTC)
The ideal candidate will be responsible for building and maintaining a strong sales pipeline. You will do so by identifying key business opportunities and segmented prospects. Your goal will be to meet or exceed our annual quota and increase our revenue. Responsibilities Giving valuable inputs to Sales and Marketing Manager in planning of a customized annual national sales strategy, including but not limited to distributors, doctors, hospitals, and institutions Identify competitive opportunities within the market and advice decisively to Sales and Marketing Manager ways to capitalize on opportunities on a continual basis Work with the Sales and Marketing Manager in preparing monthly forecasting, sales planning, and other initiatives demanding field and customers input. Regularly meet the distributors, doctors, hospitals and institutions Build rapport with distributors, doctors and purchase departments to gain the knowledge of rapid selling brands in the domain and any other useful feedback Review and support day to day activities of Executive-Sales Operation Responsible to set-up surveys with key customers leveraging their feedback for effective sales strategy and/or innovation Manage entire North Zone and allocated part of NCR Ensure effective planning of field travel Qualifications Currently in a sales management role for ophthalmologic medical devices Considerable experience working across geographical regions in India, with impressive sales growth record At least 3 years’ experience leading commercial activities in ophthalmic medical devices/ pharmaceutical industry with experience including, marketing plan development, selecting and managing distributors, and key account management Hand on experience on working on India Mart and other online marketing and sales portals Possess good leadership skills with ability to coach, motivate and impact people and results remotely Experience in managing multiple distributors is critical Excellent poise and confidence when interacting with physicians, hospital administrators, and sales staff Requires frequent travelling
Responsibilities Manage New Product Development. Manage Existing Product Development. Manage improvement of current procedures and techniques. Review, update or create technical documentations including but not limited to Product Design files, Technical Drawings and Change Control forms. Managing partnerships with vendors and other entities as well as developing new ones. Review or create Standard Operating Procedures (SOPs) related to product manufacturing and R&D processes. Conduct research for design development including but not limited to similar product evaluation and material research. Conduct product related tests and inspections. Conduct product studies by reviewing processes. Qualifications Have managed team of 3 or more people. Bachelor’s degree in Mechanical Engineering/Industrial Engineering/Biotechnology /Product Design/Industrial Design or other relevant field(s). Proficiency with Computer Aided Design software preferably Fusion360 or SolidWorks. Proficiency with measurement instruments; Vernier calliper, Micrometre, etc. Ability to take rational decisions. Problem solving attitude. Proficiency in English language. Creativity. Bachelor’s degree in Mechanical Engineering/Industrial Engineering/Biotechnology /Product Design/Industrial Design or other relevant field(s). 5-8 years of experience in research & development related fields.
Responsibilities Manage and maintain the Director’s calendar, including scheduling meetings, appointments, and travel arrangements. Act as the first point of contact for internal and external communications on behalf of the Director. Prepare and edit correspondence, reports, presentations, and other documents as needed. Coordinate and support meetings, including preparing agendas, taking minutes, and following up on action items. Maintain confidential and sensitive information with the utmost integrity. Liaise with internal departments and external stakeholders to ensure seamless communication. Assist in preparing for meetings, conferences, and events. Manage special projects and conduct research as directed by the Director. Organize and maintain physical filing systems. Be prepared to handle daily unforeseen tasks and challenges. Qualifications Proven experience (3+ years) as an executive assistant or in a similar administrative role. Exceptional organizational and time-management skills. Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and virtual communication platforms (Zoom, MS Teams). Ability to work independently with minimal supervision and adapt to changing priorities. High level of discretion and professionalism. Strong problem-solving abilities and attention to detail. Proficient in English language -Verbal and written. Bachelor’s degree preferred; additional qualifications in Office Administration are a plus.
Responsibilities Manage New Product Development. Manage Existing Product Development. Manage improvement of current procedures and techniques. Review, update or create technical documentations including but not limited to Product Design files, Technical Drawings and Change Control forms. Managing partnerships with vendors and other entities as well as developing new ones. Review or create Standard Operating Procedures (SOPs) related to product manufacturing and R&D processes. Conduct research for design development including but not limited to similar product evaluation and material research. Conduct product related tests and inspections. Conduct product studies by reviewing processes. Qualifications Have managed team of 3 or more people. Bachelor’s degree in Mechanical Engineering/Industrial Engineering/Biotechnology /Product Design/Industrial Design or other relevant field(s). Proficiency with Computer Aided Design software preferably Fusion360 or SolidWorks. Proficiency with measurement instruments; Vernier calliper, Micrometre, etc. Ability to take rational decisions. Problem solving attitude. Proficiency in English language. Creativity. Bachelor’s degree in Mechanical Engineering/Industrial Engineering/Biotechnology /Product Design/Industrial Design or other relevant field(s). 5-8 years of experience in research & development related fields.
Company Description Madhu Instruments Pvt Ltd (MIPL) manufactures high quality medical devices specializing in ophthalmology. Our commitment towards quality is paramount. With a proven track record of cutting-edge innovation and a reputation for adhering to the international best practices, quality compliance and reliability, we offer a myriad of ophthalmic devices to ensure best care for patients and hassle-free procedures for the doctors. Role Description Assist in New Product Development. Assist in Existing Product Development. Assist in improvement of current procedures and techniques. Create, update, or review technical documentations including but not limited to Product Design files, Technical Drawings and change control forms. Managing partnerships with vendors and other entities as well as developing new ones. Create or review Standard Operating Procedures (SOPs) related to product manufacturing and R&D processes. Conduct research for design development including but not limited to similar product evaluation and material research. Conduct product studies by reviewing processes. Requirements Bachelors in Mechanical Engineering/Industrial Engineering/Biotechnology/Product Design/Industrial Design or other relevant field(s). Proficiency with Computer Aided Design software preferably Fusion360 or SolidWorks. Proficiency with measurement instruments. Problem solving attitude. Proficiency in English language. Ability to work independently. Willingness to learn. Team-oriented personality. Creativity. Qualifications 3-5 years of experience in research & development related fields.
The ideal candidate will be responsible for building and maintaining a strong sales pipeline. You will do so by identifying key business opportunities and segmented prospects. Your goal will be to meet or exceed our annual quota and increase our revenue. Responsibilities Giving valuable inputs to Sales and Marketing Manager in planning of a customized annual national sales strategy, including but not limited to distributors, doctors, hospitals, and institutions Identify competitive opportunities within the market and advice decisively to Sales and Marketing Manager ways to capitalize on opportunities on a continual basis Work with the Sales and Marketing Manager in preparing monthly forecasting, sales planning, and other initiatives demanding field and customers input. Regularly meet the distributors, doctors, hospitals and institutions Build rapport with distributors, doctors and purchase departments to gain the knowledge of rapid selling brands in the domain and any other useful feedback Review and support day to day activities of Executive-Sales Operation Responsible to set-up surveys with key customers leveraging their feedback for effective sales strategy and/or innovation Manage entire North Zone and allocated part of NCR Ensure effective planning of field travel Qualifications Currently in a sales management role for ophthalmologic medical devices Considerable experience working across geographical regions in India, with impressive sales growth record At least 3 years’ experience leading commercial activities in ophthalmic medical devices/ pharmaceutical industry with experience including, marketing plan development, selecting and managing distributors, and key account management Hand on experience on working on India Mart and other online marketing and sales portals Possess good leadership skills with ability to coach, motivate and impact people and results remotely Experience in managing multiple distributors is critical Excellent poise and confidence when interacting with physicians, hospital administrators, and sales staff Requires frequent travelling
Urgent Job opening for Quality Assurance Executive Responsibilities · To handle all activities related quality management system, Quality Assurance & regulatory affairs for ISO 9001 & 13485, 93/42/EEC Directive including- · Technical files making & updating including risk management, clinical evaluation, post market surveillance, quality plan, ESRs, etc. · Fulfilment of regulatory requirements related to EC directive, various Govt. tenders & registration of overseas. · Follow up of local regulatory & drugs requirements. · Validation- machines, processes, clean rooms, material & sterilization. · Organizing internal & external audits including notified bodies audits related to quality management system & CE and follow up of non-closure reports. · Dealing in customer complaints, investigating, root cause analysis and replying, vigilance reporting & recall. · MRM- Organizing & follow up actions from previous meetings. · Review & modification in all the SOPs & manuals. · Master list of records- Establishment & updating. · Master list of documents- Establishment & updating. · Deviations- Follow up & records · Corrective & preventive actions- Corrections, implementations & maintenance. · Calibration of equipment and machines of production & quality control. · Handling out the pre-dispatch inspections of shipments by the outside agencies and certification bodies. · Training- Planning & Imparting Qualifications · Work experience should be minimum 1-2 years in medical devices manufacturing. · Excellent computer skills · Goal Oriented · Strong communication skills, including the ability to explain and teach methodologies · Understanding of manufacturing methods and quality standards · A confident and determined approach · Excellent organizational & time management skills Team player
Conduct market research to identify selling possibilities and evaluate customer needs . Maintain relationships with clients by providing solution to their queries, giving them correct information, recommending profit improvements. Handle receipt, review and on time dispatch of orders to customers Coordination with dealers to motivate them to increase their sales & understand their problems. Maintains quality service by establishing and enforcing organization standards. Prepare and deliver appropriate presentations on products to the clients. Participate on behalf of the company in exhibitions and conferences. Prepares reports by collecting, analyzing, and summarizing information. Handling CRM. Maintaining records of sales and customers. To ensure proper control of logistics costs, inventory costs and freight costs as per budget. Negotiate/close deals with clients. Collaborate with other department teams to achieve individual and organizational goals. Requirements: Vast experience of handling international customers Knowledge of required export shipment documents Currently in a backend Export sales role for medical devices company Hands on experience on advanced Excel Knowledge of export sales Cycle and its basic requirements Knowledge of CRM systems usage Ability to build relationships with key stakeholders. Self-motivated and a proactive attitude Excellent communication skills, cross functional experience and strong interpersonal skills Team Player with positive attitude ready to work in a fast-paced environment Key Capabilities and Competencies: 1. Positive attitude 2. Goal focused 3. Effective leadership and team management skills 4. Proficient in MS office with excellent Excel and Ppt skills 5. Adaptive to technology updates, using CRMs, etc 6. Excellent communication skills Interested candidates can send their updated resume (hr@madhuinstruments.com) or can call 8130384348
As a Senior Executive Quality Assurance (QA), your role involves ensuring compliance with regulatory requirements and maintaining quality standards in the medical device industry. Here is a breakdown of your key responsibilities: - Device Master File Compliance: - Draft the Device Master File to align with Indian Medical Device Rule 2017 requirements, ensuring full compliance for regulatory submissions and audits. - Clinical Data Collection and Compilation: - Collect and compile data related to device safety and performance from scientific journals and databases, including EMBASE, PubMed, and Cochrane, to support regulatory submissions and product evaluations. - Technical Documentation and Regulatory Compliance: - Assist in drafting technical documents, including Biological Evaluations, Risk Management, and Usability Reports, in compliance with EUMDR 2017/745 regulations. - Prepare and manage technical files for certification audits to meet EUMDR 2017/745 standards, ensuring that all documentation is thorough and accurate. - Quality Management System (QMS) Compliance: - Ensure thorough understanding and implementation of QMS standards as per ISO 13485:2016 and Annexure IX of EUMDR 2017/745. - Maintain and update all QMS documentation, including manuals, procedures, and policies, to ensure ongoing compliance with quality standards. - Quality Documentation Management: - Create, update, and manage company quality documentation, ensuring that manuals, procedures, and records are maintained accurately. - Monitor and enforce consistent implementation of quality management systems across the organization. - Audit Management: - Coordinate internal and external audits, including those conducted by notified bodies, focusing on QMS and CE marking. - Address any non-conformance reports promptly and efficiently, working toward continuous improvement. - Customer Complaint and Incident Management: - Handle customer complaints through root cause analysis and responsive solutions, addressing vigilance reporting and managing product recalls as necessary to maintain product integrity and customer satisfaction. Your qualifications for this role include proficiency in Device Master File Compliance, Clinical Data Collection and Compilation, Technical Documentation and Regulatory Compliance, Quality Management System (QMS) Compliance, Quality Documentation Management, Audit Management, and Customer Complaint and Incident Management. These qualifications will enable you to effectively carry out the responsibilities outlined above.,
Company Overview Madhu Instruments Pvt. Ltd. is a leader in precision medical device manufacturing, committed to innovation, quality, and global regulatory compliance. With state-of-the-art facilities and a customer-centric approach, we develop and deliver cutting-edge diagnostic and therapeutic products that improve patient outcomes worldwide. Senior Executive – Quality Assurance (Design File Compliance) Department: Quality Assurance Reports To: QA Manager Collaborates With: R&D | Regulatory Affairs | Manufacturing | Senior Leadership Location: Delhi Objective Ensure the compliant compilation, documentation, and maintenance of Design History Files (DHF), Design Files, and Technical Documentation for medical devices. Adhere to ISO 13485:2016, FDA 21 CFR Part 820, and EU MDR 2017/745, guiding cross-functional teams to meet regulatory timelines and audit readiness. Key Responsibilities Design File Compliance Develop and maintain DHF/Design Files and Technical Documentation per: ISO 13485:2016 (Clause 7.3 – Design & Development) FDA 21 CFR 820.30 (Design Controls) EU MDR 2017/745 (Articles 10, 61, 83; Annexes II & III) Include device description, intended purpose, specifications, GSPR checklist, risk management (ISO 14971), verification/validation protocols, clinical evaluation reports, and PMS plans. Ensure full traceability between design inputs, outputs, risk controls, and regulatory requirements. Cross-Functional Coordination Liaise with R&D, Regulatory Affairs, Manufacturing, and Clinical teams to gather and consolidate inputs. Align documentation with EU MDR Annex III (PMS Technical Documentation) and track actions for CE marking and FDA 510(k) submissions. Timeline Management & Reporting Develop and monitor project timelines, integrating EU MDR milestones (e.g., PMS updates, CER revisions). Provide regular (weekly/monthly) updates on progress, compliance gaps, and risks to the QA Manager, R&D Manager, and Managing Director. Regulatory Audit & Inspection Readiness Prepare DHF and Technical Documentation for Notified Body audits, FDA inspections, and internal audits. Address findings related to EU MDR compliance (clinical evaluation, PMS data, UDI traceability) and FDA observations. Risk Management & Post-Market Surveillance Collaborate with Risk Management to ensure files reflect EU MDR Annex I (GSPR) and Annex III (PMS requirements). Support updates to risk management files and PMS reports post-market launch. Qualifications Education: Bachelor’s degree in pharmacy (B. Pharma) or Biomedical Sciences or Diploma in Regulatory Affairs or M. Tech in Medical Devices Experience: 3+ years in QA/RA within the medical device industry Hands-on experience with DHF/Technical Documentation under FDA 21 CFR 820 and EU MDR 2017/745 Familiarity with Annex II/III requirements, clinical evaluation reports (CERs), PMS, and clinical evidence Skills: Strong understanding of EU MDR Articles 10, 61, 83 and GSPR checklist implementation Expertise in cross-functional project management and timeline tracking Preferred Attributes Certification in Regulatory Affairs (RAC) or Quality Auditing (CQA). Experience with UDI requirements under EU MDR and FDA. Knowledge of the EUDAMED database and technical documentation submissions.
Company Overview Madhu Instruments Pvt. Ltd. is a leader in precision medical device manufacturing, committed to innovation, quality, and global regulatory compliance. With state-of-the-art facilities and a customer-centric approach, we develop and deliver cutting-edge diagnostic and therapeutic products that improve patient outcomes worldwide. Senior Executive Quality Assurance (Design File Compliance) Department: Quality Assurance Reports To: QA Manager Collaborates With: R&D | Regulatory Affairs | Manufacturing | Senior Leadership Location: Delhi Objective Ensure the compliant compilation, documentation, and maintenance of Design History Files (DHF), Design Files, and Technical Documentation for medical devices. Adhere to ISO 13485:2016, FDA 21 CFR Part 820, and EU MDR 2017/745, guiding cross-functional teams to meet regulatory timelines and audit readiness. Key Responsibilities Design File Compliance Develop and maintain DHF/Design Files and Technical Documentation per: ISO 13485:2016 (Clause 7.3 Design & Development) FDA 21 CFR 820.30 (Design Controls) EU MDR 2017/745 (Articles 10, 61, 83; Annexes II & III) Include device description, intended purpose, specifications, GSPR checklist, risk management (ISO 14971), verification/validation protocols, clinical evaluation reports, and PMS plans. Ensure full traceability between design inputs, outputs, risk controls, and regulatory requirements. Cross-Functional Coordination Liaise with R&D, Regulatory Affairs, Manufacturing, and Clinical teams to gather and consolidate inputs. Align documentation with EU MDR Annex III (PMS Technical Documentation) and track actions for CE marking and FDA 510(k) submissions. Timeline Management & Reporting Develop and monitor project timelines, integrating EU MDR milestones (e.g., PMS updates, CER revisions). Provide regular (weekly/monthly) updates on progress, compliance gaps, and risks to the QA Manager, R&D Manager, and Managing Director. Regulatory Audit & Inspection Readiness Prepare DHF and Technical Documentation for Notified Body audits, FDA inspections, and internal audits. Address findings related to EU MDR compliance (clinical evaluation, PMS data, UDI traceability) and FDA observations. Risk Management & Post-Market Surveillance Collaborate with Risk Management to ensure files reflect EU MDR Annex I (GSPR) and Annex III (PMS requirements). Support updates to risk management files and PMS reports post-market launch. Qualifications Education: Bachelor's degree in pharmacy (B. Pharma) or Biomedical Sciences or Diploma in Regulatory Affairs or M. Tech in Medical Devices Experience: 3+ years in QA/RA within the medical device industry Hands-on experience with DHF/Technical Documentation under FDA 21 CFR 820 and EU MDR 2017/745 Familiarity with Annex II/III requirements, clinical evaluation reports (CERs), PMS, and clinical evidence Skills: Strong understanding of EU MDR Articles 10, 61, 83 and GSPR checklist implementation Expertise in cross-functional project management and timeline tracking Preferred Attributes Certification in Regulatory Affairs (RAC) or Quality Auditing (CQA). Experience with UDI requirements under EU MDR and FDA. Knowledge of the EUDAMED database and technical documentation submissions.
JOB DESCRIPTION: EXECUTIVE ASSISTANT Responsibilities Manage and maintain the Director’s calendar, including scheduling meetings, appointments, and travel arrangements. Act as the first point of contact for internal and external communications on behalf of the Director. Prepare and edit correspondence, reports, presentations, and other documents as needed. Coordinate and support meetings, including preparing agendas, taking minutes, and following up on action items. Maintain confidential and sensitive information with the utmost integrity. Liaise with internal departments and external stakeholders to ensure seamless communication. Assist in preparing for meetings, conferences, and events. Manage special projects and conduct research as directed by the Director. Organize and maintain physical filing systems. Be prepared to handle daily unforeseen tasks and challenges. Qualifications Proven experience (3+ years) as an executive assistant or in a similar administrative role. Exceptional organizational and time-management skills. Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and virtual communication platforms (Zoom, MS Teams). Ability to work independently with minimal supervision and adapt to changing priorities. High level of discretion and professionalism. Strong problem-solving abilities and attention to detail. Proficient in English language -Verbal and written. Qualification Bachelor’s degree preferred; additional qualifications in Office Administration are a plus. Salary-35k-40k (CTC)