Job Title: Clinical Research Lead Location: Bangalore Company: Janitri Innovations Pvt. Ltd. About Janitri Innovations Pvt. Ltd.: Janitri is a social enterprise with a vision to create a world where no mother or newborn dies during pregnancy, birth, or post-delivery. We innovate and develop medical devices and technologies to improve maternal and newborn health. Our focus is on bringing impactful solutions to healthcare through continuous research and clinical studies on maternal-fetal health monitoring technology. Job Summary: The Clinical Research Lead will take charge of leading clinical studies from initiation to completion. This role involves overseeing clinical trials, coordinating with hospitals and stakeholders, ensuring the quality of data collection and analysis, and leading research initiatives. The ideal candidate will have experience in clinical research, especially within the medical device sector, and be skilled in designing studies, managing execution, and ensuring scientific rigor. Key Responsibilities: Leadership in Clinical Studies: Lead the execution and coordination of ongoing and new clinical studies in collaboration with hospitals, PIs (Principal Investigators), and research teams. Oversee all phases of clinical studies from concept development, protocol design, and sample size calculation to execution, ethics approval, and data analysis. Study Design & Execution: Design clinical research protocols in accordance with scientific guidelines and regulatory standards. Work closely with the study team to ensure smooth execution of clinical trials, including participant recruitment, data collection, and study monitoring. Data Analysis & Reporting: Lead data analysis and generate reports using statistical tools (e.g., SPSS, SAS, Excel, Matlab, Python). Provide insights through data interpretation, ensuring data integrity, and maintaining detailed records of study findings. Stakeholder Management: Regularly engage with key stakeholders such as hospital teams, public health experts, and internal staff to track progress, resolve issues, and drive study success. Facilitate meetings and discussions with stakeholders to ensure alignment on study objectives and timelines. Regulatory & Ethics Coordination: Ensure all studies comply with regulatory guidelines and secure necessary ethics approvals. Liaise with ethics boards, hospitals, and government authorities for study submissions and compliance requirements. Manuscript Writing & Publications: Lead the writing and publication of scientific papers and reports based on research findings. Collaborate with the public health team on research publications and ensure high-quality submissions to relevant journals. Team Collaboration & Mentorship: Mentor junior clinical research staff and provide guidance on study design, execution, and data analysis. Collaborate with cross-functional teams (product, public health, and regulatory) to align clinical study outcomes with company goals. Skills, Knowledge, and Experience: Minimum 4 years of experience in clinical research, with at least 2 years in a leadership role within the medical device or healthcare industry. Strong understanding of clinical research methodologies and statistical analysis. Proficiency in statistical analysis software (SPSS, Matlab, Python, SAS, Excel) and other relevant tools. Experience in study design, protocol writing, sample size calculation, and data management for clinical trials. Strong project management skills with a focus on delivering quality results on time. Proven experience in coordinating with ethics boards and securing regulatory approvals. Excellent communication, interpersonal, and leadership skills with proficiency in English. Experience in writing and publishing research papers in scientific journals. Why Join Us? This role offers the opportunity to lead impactful research that will directly contribute to improving maternal and newborn health outcomes. If you are passionate about clinical research and want to be part of an innovative team making a difference, we encourage you to apply.

About Janitri Janitri is a Med-tech company that develops IoT-based smart pregnancy and newborn monitoring devices. Apart from a recent feature in Shark Tank, Janitri has won numerous awards and accolades for its life-saving innovations. About the position: We are seeking a highly motivated and experienced Senior Regulatory and Quality Assurance Specialist to join our team. The successful candidate will be responsible for ensuring compliance with regulatory requirements and maintaining high-quality standards throughout the product lifecycle of Class II medical devices. This role requires a deep understanding of regulatory affairs, quality management systems, and strong attention to detail. Roles and Responsibilities: Regulatory Compliance: Lead regulatory submissions (510(k), Technical Files, Design Dossiers) for Class II medical devices to regulatory authorities (FDA, Notified Bodies, etc.). Interpret and apply regulations (FDA QSR, ISO 13485, MDR, etc.) to ensure compliance of products and processes. Monitor changes in regulations and communicate potential impacts to relevant stakeholders. Quality Management Systems: Develop, implement, and maintain quality management systems (QMS) to ensure compliance with regulatory requirements and industry standards. Conduct internal audits and oversee external audits to assess QMS effectiveness and identify areas for improvement. Manage corrective and preventive action (CAPA) processes to address quality issues and prevent recurrence. Product Lifecycle Management: Provide regulatory guidance and support to cross-functional teams throughout the product life cycle, from product development to post-market surveillance. Review and approve design control documentation, including design inputs, verification/validation plans, and risk management activities. Support regulatory assessments of product changes and design modifications. Compliance Documentation: Prepare and maintain regulatory documentation, including regulatory submissions, technical documentation, and quality records. Ensure documentation is accurate, complete, and in compliance with applicable regulations and standards. Required Skills: Bachelor's degree in a relevant scientific or engineering field; advanced degree preferred. Minimum of 10+ years of experience in regulatory affairs and quality assurance within the medical device industry, with specific experience in Class II devices. In-depth knowledge of FDA regulations (21 CFR Part 820), ISO 13485, and other relevant standards. Experience with regulatory submissions, including 510(k) applications and Technical Files. Strong analytical skills and attention to detail. Excellent written and verbal communication skills. Ability to work effectively in a cross-functional team environment.

Responsibilities: Record and maintain day-to-day financial transactions in accounting software (Tally, Zoho Books, or equivalent) Prepare and manage invoices, purchase orders, vendor payments, and expense reimbursements Conduct bank reconciliations, monitor account balances, and maintain ledger accuracy Manage GST, TDS, and other statutory filings and ensure compliance with tax regulations Assist in monthly and annual financial closings, journal entries, and audit preparation Maintain organized documentation for all financial transactions Support payroll-related calculations and coordinate with HR on salary inputs Coordinate with vendors, clients, and internal teams for smooth accounting operations Prepare regular MIS reports for internal stakeholders Qualifications: Bachelor’s degree in Commerce, Accounting, or related field 2–3 years of hands-on experience in accounting, preferably in a startup, healthcare, or manufacturing environment Proficient in Tally, Zoho Books, or similar accounting platforms Solid understanding of GST, TDS, income tax, and general compliance Proficient in MS Excel and working knowledge of basic financial reporting Strong attention to detail, accuracy, and organizational skills Experience in managing accounts in a growing or impact-led organization Exposure to inventory accounting or medical device sector is a plus Why Join Janitri? Be part of a company driving impact in maternal and newborn health Work in a dynamic and collaborative team environment Opportunities for growth and learning in a purpose-driven organization Competitive compensation and supportive work culture

Roles and Responsibilities: Responsible for managing the entire supply chain, from the procurement to the dispatching of the products. Vendor management, and Supplier negotiations. Managing cost cuttings on various fronts to bring down the BOM cost. May need to look after a part of the manufacturing as well. Weekly MIS and STOCK updation for finished goods as well as Raw materials. STOCK updates from suppliers to avoid critical bottlenecks in the manufacturing. * Required Skills: 1+ years experience in production and manufacturing of electrical device Should have a good understanding of the domestic as well as overseas market. Exposure to electronic manufacturing is a bonus (Mechatronics). Must have the discipline and commitment to own the project. Native language speakers would be preferred. Good communication skills – both written and oral Good with Documentation