Regulatory Affairs Specialist

Dozee

3 - 5 years

11 - 13 Lacs

Bengaluru

Posted:1 day ago| Platform:

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Skills Required

Medical devices Nursing Manager Quality Assurance Project management Consulting Manager Technology Healthcare Risk management Analytics Auditing

Work Mode

Work from Office

Job Type

Full Time

Job Description

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 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 CAPAs 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

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