Regulatory Affairs Specialist

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.

Role Overview:  As a Lead Regulatory Affairs Specialist at Dozee, you will drive global regulatory strategy for our medical devices and SaMD products. You will manage regulatory submissions, ensure compliance with FDA, EU MDR, and international standards, and mentor a growing regulatory team. This role offers the chance to shape the regulatory landscape of innovative healthcare technologies, ensuring safety, efficacy, and timely market access worldwide.

Responsibilities: Plan, establish and maintain a Quality Management System in accordance with EN ISO 13485

Implement regulatory strategies for maintaining compliance with established standards like IEC 60601, IEC 62304, US FDA and CE Marking, etc

Prepares dossiers and device master files for regulatory submissions

Follow the Medical Device Act by CDSCO and other relevant regulations related to products developed and provide directions for compliance to the organization.

Work with different teams to setup Quality policies and standards

Ensuring all established quality and delivery commitments are met such as working within FDA regulations, Design Control and ISO Standards.

Training and ensuring all assigned employees are aware of and comply with company policies, government procedures, and regulations.

Working closely with product development and product transfer teams Supplier Audit and Qualification. Turtle Shell Technologies Private Limited No. 40, City Centre, Chinmaya Mission Hospital Road, Bengaluru (Bangalore) Urban, Karnataka - 560038

Assist with Management Review meetings including generation of quality metrics and coordinating the review.

Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal procedures to assure compliance for QMS.

Lead audit and inspection preparation, resolution of audit and inspection findings with relevant stakeholders through all stages of the audits.

Coordinate CAPA's meetings and provide assistance to the corrective action owners to ensure effectiveness.

Ensure employee training compliance to Corporate and site-level QMS. May be responsible for preparing and facilitating quality related training programs for employees.

Requirements: Educational Qualification- B.Tech

Minimum 3-5 years of experience in Medical Device Regulation. Experience with international medical device regulatory approvals and submissions

Experience supporting regulatory agency inspections and Notified Body Audits in an SME role

Demonstrated knowledge of US FDA, EU MDR, ISO 13485 Quality Management System and ISO 14971 Risk Management for Medical Devices as well as IEC 62304

Ability to analyze and interpret standards, technical procedures, professional journals and governmental guidance and regulation documents

Proven experience in new medical device registrations and filings

Working experience with CDSCO, Notified body and other associations for medical device regulation ● Able to constructively collaborate with cross-functional teams

Working knowledge of quality assurance methodologies

Knowledge of commonly-used concepts, practices, and procedures for a full product development life-cycle and Medical Device Quality Management System.

Support compliance assessments to ensure quality and regulatory requirements are successfully implemented and maintained.

Providing guidance to the team to interpret regulatory requirements for various life-cycle stages of the project

Drive Good Documentation practices.

Ability to follow instructions, work independently, or function in a team as needed

Highly organized, process orientated and adherence to standard process.

Exhibit good leadership across departments and teams.

Good time management and project management.

Collaborative and a team player, with good interpersonal, listening and communication skills

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