Regulatory Affairs Specialist
- Dozee
- 3 - 5 years
- Bengaluru
- 3 months ago
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Job Description
- 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
Job Classification
Industry: Medical Devices & EquipmentFunctional Area / Department: Legal & RegulatoryRole Category: Corporate AffairsRole: Regulatory Affairs ComplianceEmployement Type: Full timeContact Details:
Company: DozeeLocation(s): Bengaluru+ View Contact
Keyskills: Medical devices Nursing Manager Quality Assurance Project management Consulting Manager Technology Healthcare Risk management Analytics Auditing
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Dozee
Dozee is Indias 1st AI-based contactless Remote Patient Monitoring (RPM) Early Warning System (EWS) for continuous patient monitoring with a mission to develop deploy intelligent technologies, solutions, and networks to provide a continuum of care, early warning systems, and responses to save lives.
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