Regulatory Affairs Specialist
Full time
at Dozee
in
Online
Posted on December 26, 2024
Job details
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.
- 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.
- 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
- 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
- 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.
- 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, 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 2020
- Marico Innovation For India Award
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