We at Phoenix Medical Systems Pvt. Ltd., based in Chennai and established in 1987, are committed to enhancing maternal and neonatal care by developing high-quality, affordable medical equipment. Our range includes infant warmers, incubators, phototherapy units, CPAP systems, and delivery beds. With a presence in over 60 countries, we serve hospitals and healthcare providers worldwide with reliable and innovative solutions. JOB OVERVIEWWe are seeking a Regulatory Specialist with a strong background in medical device regulatory submissions, particularly for US FDA (510(k)), EU MDR, and IMDR. The ideal candidate will have hands-on experience in compiling technical documentation, understanding global regulatory frameworks, and supporting cross-functional teams to ensure timely and compliant submissions. Key Responsibilities: To Prepare the technical dossier and ensure all technical and regulatory documents are accurately completed and submitted in a timely manner for 510(k) US FDA , European CE ( EU MDR) and CDSCO SubmissionTo Collaborate with cross-functional teams (R&D, Quality, Marketing) to define regulatory strategies and ensure alignment with regulatory requirements.To ensure products and submissions comply with FDA regulations, standards (e.g., 21 CFR 820), and guidance documents and EU MDR regulations. To address regulatory questions and manage any follow-up communications related to submissions. To monitor and track submission timelines and follow up on the status of pending approvals. Ensure timely responses to requests for additional information from the FDA.Continuously monitor changes to national/international/regulatory standards, guidance documents, and industry standards to ensure all submissions are in compliance with current regulatory requirements.To review product labeling, technical files, risk assessments, and other documentation for regulatory compliance.To Provide guidance and regulatory support to various departments, including Quality Assurance, Engineering, and Marketing.Maintain up-to-date, well-organized records of regulatory submissions and all related documentation, ensuring easy access for audits or reviews. Requirements:Education: Bachelor's / Master degree in Biomedical Engineering, Bio-Medical Instrumentation, or a related field.Experience: 2–3 years of relevant experience with direct involvement in 510(k) and EU MDR technical documentation.Knowledge:Strong understanding of ISO 13485, FDA 21 CFR 820, EU MDR, and IMDR regulations.Familiar with GSPR, risk management (ISO 14971), and clinical evaluation.Technical Skills: Experience using document management systems and regulatory submission tools.Communication: Excellent written and verbal communication skills.Problem-Solving: Ability to manage complex regulatory challenges independently.Teamwork: Proven ability to work cross-functionally with minimal supervision. Preferred Qualifications:Certification in ISO 13485, EU MDR and 510 (K) Experience with other geographical regulatory submissions Familiarity with international regulatory requirements

Role Summary Join Phoenix Medical’s R&D team to design, develop, and validate embedded software for life-saving medical devices. Work with cross-functional teams to build safety-critical systems compliant with global medical standards. Key Responsibilities Design & develop embedded firmware for medical devices using STM32, PIC, and ATmega microcontrollers . Implement communication protocols ( I2C, SPI, UART, USB ) and drivers for sensors, actuators, displays, and other hardware peripherals. Develop safety-critical software compliant with IEC 62304, ISO 13485, ISO 14971, and IEC 60601 standards. Optimize power management and real-time performance using Azure RTOS/ThreadX . Conduct hardware-software integration testing, root cause analysis, and defect resolution. Collaborate with hardware, verification, and regulatory teams to ensure product reliability. Maintain version control ( SVN/Git ) and technical documentation. Required Skills & Qualifications Technical: Minimum 2 years of embedded C/C++ development in medical devices . Expertise with ARM Cortex-M (STM32/NXP) and 8/16-bit MCUs (PIC24/PIC32/ATmega). Hands-on experience with I2C, SPI, UART , sensors, and display interfaces. Knowledge of RTOS (Azure RTOS, FreeRTOS, or similar). Familiarity with medical standards ( IEC 62304, ISO 13485, IEC 60601 ). Soft Skills: Analytical troubleshooting of hardware-software issues. Ability to work in cross-functional teams. Strong documentation practices. Preferred Skills Experience with Battery Management Systems (BMS) . Knowledge of USB, Ethernet, WiFi stacks . Exposure to risk management (ISO 14971) . Familiarity with oscilloscopes, logic analyzers, and JTAG debuggers. Why Join Us? Location: Modern R&D facility in Thirumudivakkam. Flexibility: Flexible hours. Impact: Build cutting-edge medical tech improving patient outcomes. Growth: Trainings in emerging MEDtech solutions About PMS INDIA Website : Phoenix Medical Systems | Enabling Life Phoenix Medical Systems is a manufacturer of infant and maternal care products and assistive devices. Phoenix was created in 1989 with the goal of providing cost-effective and innovative neonate-care solutions. The mission of Phoenix continues to be to provide solutions that match the best in the world at very affordable prices. The Phoenix range of maternal and infant care products includes warming systems, jaundice management units, respiratory care equipment, and obstetric and gynecological tables. Phoenix also makes SmartCane, an electronic travel aid, refreshable braille readers, and standing wheelchairs. Phoenix products are used at thousands of hospitals across India and in 32 countries in Africa, Europe, the Asia Pacific region, South America, and the Middle East.

About Phoenix Medical Systems Phoenix Medical Systems Private Limited is a pioneer in infant-care products in India, with facilities in Chennai and Pondicherry. The company focuses on innovation and quality, manufacturing world-class neonatal and maternal-care equipment that match international standards. Phoenix exports its products to more than 35 countries across the globe. Phoenix was established in 1989 with the goal of providing cost-effective and innovative neonate-care solutions. The mission of Phoenix continues to be to provide solutions that match the best in the world at very affordable prices. The Phoenix range of maternal and infant care products includes warming systems, jaundice management units, respiratory care equipment, and obstetric and gynecological tables. Job Summary We are looking for Hardware Lead who is ready to work on new ideas for products that can cure complications in new-borns, especially who need assistance just after birth. Knowledge of microcontroller based hardware design, sensors, drivers, Power electronics, Battery management and good EMI/EMC compliance relating to medical devices is a must for this position. Responsibilities and Duties Hardware Design Engineer with strong experience in design & development of Medical grade PCBs. Good understanding of design complying EMI- EMC testing as per medical device standards Understanding of risk management for medical devices Develop schematics and layouts as per design requirements and manufacturing feasibility. Developing Embedded Hardware (Electronics) Digital, Analog and Mixed Signal Processing Manage BOM with standard ECR/ECN processes Component selection and handle component suppliers and PCB Fabricators. Skills Hardware Development and Electronics Hardware Design skills Experience in hardware architecture and circuit design Hardware Design skills in high-speed digital design, signal and power integrity, and EMI/EMC Experience with PCB design tools and simulation software Knowledge of processor and RTOS architecture and system design Bachelor's or Master's degree in Electrical/Electronics Engineering or related field Excellent written and verbal communication skills Ability to work in a team-oriented environment Experience with medical standards IEC60601 is desirable Experience in EMI/EMC Compliance

As a Hardware Lead at Phoenix Medical Systems Private Limited, you will be responsible for the design and development of Medical grade PCBs, focusing on creating innovative products to address complications in newborns. Your expertise in microcontroller based hardware design, sensors, drivers, Power electronics, Battery management, and EMI/EMC compliance for medical devices will play a crucial role in this position. You will be involved in developing schematics and layouts according to design requirements and manufacturing feasibility, along with managing the Bill of Materials (BOM) using standard ECR/ECN processes. Your responsibilities will also include working on Embedded Hardware (Electronics) for Digital, Analog, and Mixed Signal Processing, as well as handling component suppliers and PCB Fabricators. To excel in this role, you must possess strong hardware development and electronics hardware design skills, with experience in high-speed digital design, signal and power integrity, and EMI/EMC. Knowledge of processor and RTOS architecture, as well as familiarity with PCB design tools and simulation software, will be essential. A Bachelor's or Master's degree in Electrical/Electronics Engineering or a related field is required, along with excellent communication skills and the ability to collaborate effectively in a team environment. Prior experience with medical standards such as IEC60601 and EMI/EMC compliance will be advantageous in fulfilling the responsibilities of this position. If you are passionate about leveraging your hardware design expertise to contribute to the development of cutting-edge neonatal and maternal-care equipment, we encourage you to apply and be a part of our mission to provide affordable and innovative solutions for newborn care.,