Dozee - Specialist - Regulatory Affairs (3-5 yrs)

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.