Regulatory affairs specialist

16 hours ago

Bangalore, India Dozee Full time

Overview : Include dossier preparation, on-time tracking of applications and network with regulatory bodies and bring in compliance. Play an active role in a change environment Supports the ongoing implementation and sustainment of Quality and Regulatory compliance as per local and international rules and regulations. 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. 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 Good interpersonal, listening and communication skill About Dozee () Vision & Mission Save lives with AI-based early warning systems Develop intelligent technologies, solutions and networks to provide continuum of care, AI based early warning systems and responses to save lives. Dozee is India’s leading AI-based contactless Remote Patient Monitoring (RPM) and Early Warning System (EWS) , continuously monitors patients and provides early warnings of clinical deterioration, enabling timely interventions and enhancing patient safety in hospitals, nursing facilities and patient homes. "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 care by improving 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 Dozee in News: Bloomberg- Oct 21, 2024 News18- Oct 26, 2024 Analytics India Magazine- Oct 29, 2024 ET Health World- Sep 16, 2024 BW heathcareworld- Oct 29, 2024 , conducted at King George Medical University, Lucknow highlights the clinical & economical impact of Dozee in Tertiary Center 210 lives saved yearly for every 100 Dozee bed by lifesaving alerts Saving of INR 2.7 Cr / year for every 100 Dozee beds 10% time taken by nurses Key Highlights Founded : October, 2015 Founders : Mudit Dandwate, Gaurav Parchani Headquarters : Bangalore, India | Houston, USA | Dubai, UAE Key Investors & Backers : Prime Ventures, 3one4 Capital, Your Nest Capital, Gokul Rajaram, BIRAC (Department of Biotechnology, State Bank of India, and Dinesh Mody Ventures. Stage : Series A+ Team Strength : 280+ Business : Providing Continuum of care with AI-based contactless Remote Patient Monitoring (RPM) and Early Warning System (EWS) for Hospitals and Home. Certifications & Accreditations : ISO13485:2016 Certified, ISO27001:2022 Certified, CDSCO Registered, FDA510 K 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 2020 Marico Innovation For India Award To know more about , . 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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