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Regulatory Affairs Specialist

Dozee

Bangalore Full-time Posted 8d ago
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Overview: Dozee Health AI is a pioneer in Contactless Remote Patient Monitoring (RPM), proven to drive transformation at scale. Headquartered in Bengaluru, India, Dozee has emerged as India’s no. 1 RPM Company.  We are seeking visionary individuals to help us in this very exciting  journey. As a part of our dynamic team, you’ll have the opportunity to collaborate with top healthcare providers in the country, applying AI-powered RPM solutions to tackle some of the most pressing challenges in healthcare - enhancing staff efficiency, improving patient outcomes, and pioneering the next generation of care models. RESPONSIBILITIES * Plan, establish, implement, maintain, and continuously improve the Quality Management System (QMS) in accordance with EN ISO 13485 and applicable medical device regulatory requirements. * Drive QMS streamlining and process improvements across functions to ensure effective, efficient, and compliant quality processes throughout the product lifecycle. * Develop, review, and maintain quality policies, procedures, SOPs, work instructions, forms, and quality records in alignment with regulatory and organizational requirements. * Ensure effective implementation and maintenance of Design Controls, Document Control, Change Control, Risk Management, CAPA, Non-Conformance, Complaint Handling, Supplier Quality, Training, and other QMS processes. * Support regulatory compliance with applicable standards and regulations, including US FDA, EU MDR/CE Marking, CDSCO, IEC 60601, IEC 62304, ISO 14971, and other relevant requirements. * Prepare and maintain regulatory dossiers, Device Master Files/Technical Documentation, and quality-related documentation required for regulatory submissions and product lifecycle activities. * Work closely with Product Development, Product Transfer, Manufacturing, Engineering, and other cross-functional teams to ensure QMS and regulatory requirements are effectively implemented. * Provide guidance to cross-functional teams on quality and regulatory requirements at various stages of the medical device product lifecycle. * Conduct or support internal audits, supplier audits, Notified Body audits, and regulatory inspections, including audit preparation, coordination, response, and closure of observations/findings. * Lead the identification, investigation, implementation, and effectiveness verification of CAPAs and corrective/preventive actions. * Coordinate Management Review meetings, including preparation of quality metrics, performance indicators, inputs, action items, and follow-up activities. * Establish and monitor quality objectives, KPIs, and quality metrics to evaluate QMS effectiveness and identify opportunities for improvement. * Support supplier qualification, evaluation, monitoring, and supplier audits in accordance with established quality procedures. * Drive compliance with Good Documentation Practices (GDP) and ensure appropriate control, traceability, accuracy, and integrity of quality records. * Develop and deliver QMS and regulatory training and ensure employee awareness and compliance with applicable company policies, procedures, standards, and regulatory requirements. * Monitor changes in medical device regulations, standards, and regulatory guidance and assess their impact on the organization's QMS and products. * Support regulatory compliance assessments and gap assessments and coordinate implementation of required actions. * Ensure effective implementation of QMS processes, regulatory requirements, and quality commitments across the organization. * Identify opportunities for continuous improvement, process optimization, and QMS maturity enhancement through data-driven analysis, audit findings, CAPA trends, and management review outputs. * Maintain readiness for regulatory inspections and third-party audits and support timely and effective closure of audit observations. * Provide subject-matter expertise and guidance on QMS, quality assurance, regulatory compliance, and applicable medical device standards. REQUIREMENTS * B.Tech or equivalent educational qualification. * 3-5 years of experience in Medical Device Quality Assurance, Quality Management Systems, and/or Regulatory Affairs. * Hands-on or working knowledge of QMS implementation, streamlining, improvement, maintenance, and compliance in accordance with ISO 13485. * Experience in developing, implementing, reviewing, and maintaining QMS procedures, SOPs, work instructions, and quality records. * Working knowledge of Design Controls, CAPA, Change Control, Document Control, Non-Conformance, Risk Management, Supplier Quality, Training, Complaint Handling, and other core QMS processes. * Knowledge of US FDA, EU MDR/CE Marking, CDSCO, ISO 13485, ISO 14971, IEC 62304, IEC 60601, and other applicable medical device regulations and standards. * Experience supporting regulatory submissions, new medical device registrations, and maintenance of regulatory/technical documentation. * Experience supporting regulatory inspections, Notified Body audits, internal audits, and supplier audits, including preparation and closure of findings. * Ability to analyze and interpret regulations, standards, guidance documents, technical procedures, and regulatory requirements and translate them into practical QMS processes. * Experience in quality metrics, Management Review, CAPA effectiveness, audit readiness, and continuous improvement initiatives. * Working knowledge of Good Documentation Practices and quality documentation management. * Ability to collaborate effectively with cross-functional teams throughout the medical device product development and product transfer lifecycle. * Strong analytical, organizational, problem-solving, and process-improvement skills. * Ability to work independently while effectively collaborating with different departments and stakeholders. * Strong leadership, communication, interpersonal, project management, and time-management skills. * Highly organized, process-oriented, detail-oriented, and committed to maintaining quality, compliance, and continuous improvement. Vision & Mission Save Million lives with Health AI   Dozee is India’s leading AI-Powered contactless Remote Patient Monitoring (RPM) and Early Warning System (EWS). A solution that continuously monitors patients and provides early warnings of clinical deterioration, enabling timely interventions and enhancing patient safety in hospitals, nursing facilities and patient homes. A "Made in India for the World" solution, Dozee has pioneered the world’s first non-contact blood pressure monitoring system. Trusted by leading healthcare providers in India, the USA, and Africa, Dozee is transforming patient safety and care by enhancing outcomes and reducing costs.   Dozee is adopted by 300+ hospitals and monitors 16000+ beds across 4 countries. Dozee has monitored over 1 Mn Patients, Delivered 35000+ Life Saving Alerts and Saved 10 Mn+ Nursing Hours.    Videos - Science Behind Dozee : Ballistocardiography & Artificial Intelligence - 100 Dozee deliver 144 life saving alerts and INR 2.7 Cr of saving - Sattva Study - Dozee saves life of a mother at home - Leading Healthcare Game changers work with DozeeI - Introducing Dozee VS - Dozee Shravan - A clinical grade RPM service   Dozee in News: Bloomberg - Oct 21, 2024 From AI Beds to Remote ICUs, Startups are plugging India's health Gaps   News18Oct 26, 2024 Now, You Can Remotely Monitor Your Loved Ones in Hospital With Bengaluru Start-Up's 'Shravan'   Analytics India MagazineOct 29, 2024 Dozee Harness AI for Personalised Patient Care   ET HealthWorldSep 16, 2024 We trust AI everyday - From Google Maps to Smartphones, So why not use it to enhance patient safety in healthcare?   BW healthcareworldOct 29, 2024 Dozee's AI-Powered System Predicts Patient Deterioration 16 Hours in Advance   A tertiary care hospital study published in JMIR, validated Dozee’s Early Warning System (EWS), showing it identified 97% of deteriorating patients, provided alerts ~19 hours in advance, and generated 5x fewer alerts, reducing alarm fatigue and improving patient outcomes.   A study at King George Medical University, Lucknow, and published in Frontiers in Medical Technology demonstrated that Dozee’s automation can potentially save 2.5 hours of nursing time per shift, improving workflow efficiency and allowing more focus on patient care.   A study on remote patient monitoring in general wards published in Cureus found that 90%+ of healthcare providers reported improved care and patient safety, 74% of patients felt safer, and there was a 43% increase in time for direct patient care.   Research by Sattva, an independent consulting firm, demonstrates Dozee's substantial impact: for every 100 Dozee-connected beds, it can save approximately 144 lives, reduce nurses’ time for vital checks by 80%, and decrease ICU average length of stay by 1.3 days.   Key Highlights - Founded : October, 2015 - Founders :  Mudit Dandwate, Gaurav Parchani - Headquarters : Bangalore, India | Houston, USA | Dubai, UAE - Key Investors & Backers : Prime Ventures, 3one4 Capital, YourNest Capital, Gokul Rajaram, BIRAC (Department of Biotechnology, State Bank of India, and Dinesh Mody Ventures, Temasek Foundation, Horizons Ventures - Stage : Series A+ - Team Strength : 280+ - Business : Providing Continuum of care with AI-powered contactless Remote Patient Monitoring (RPM) and Early Warning System (EWS) for Hospitals and Home.   - Certifications & Accreditations : ISO13485:2016 Certified, ISO27001:2022 Certified, CDSCO Registered, FDA510K Cleared for the flagship product Dozee Vitals Signs (VS) measurement system and SOC2 Type II Certified   Achievements: - Forbes India 30 under 30 - Forbes Asia 100 to Watch - Times Network - India Health Awards 2024 for AI innovation in Bharat Healthcare tech - BML Munjal Award for Business Excellence using Learning and Development - FICCI Digital Innovation in Healthcare Award - Anjani Mashelkar Inclusive Innovation Award Marico Innovation For India Award.   To know more about life@dozee, click here.     Disclaimer: Dozee is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.” Dozee does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. Dozee will not tolerate discrimination or harassment based on any of these characteristics

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