FLOAID MEDTECH | Quality assurance and regulatory affairs specialist
2 weeks ago
Location: IIT Madras Research park, Chennai, India
Position Type: Quality Assurance & Regulatory Affairs (QA/RA) Specialist(Full Time)
Salary: Based on Experience
Company Overview
We, “Floaid Medtech” is an evolving venture aiming towards the development of cutting edge medical devices, motivated with “Make In India” vision. Our own vision is to provide state of the art medical technology to our nation, homegrown with international standards, at affordable prices. Our commitment to innovation, technology, and a passion for precision sets us apart, and we're looking for a Precision Manufacturing Maestro to join our symphony of excellence.
Job Summary: The QA/RA Specialist will be responsible for the development, implementation, maintenance, and overall success of the company's quality and regulatory programs. This role will ensure compliance with ISO 13485, EU MDR, US FDA, CDSCO, and other applicable regulatory requirements. The ideal candidate will drive quality standards, ensure alignment with global market requirements, and maintain inspection readiness across all regulated processes and systems.
Key Responsibilities:
- Develop, implement, and maintain the company's Quality Management System (QMS) in compliance with ISO 13485, USFDA, EUMDR, CDSCO, and other relevant regulations.
- Act as the Person Responsible for Regulatory Compliance (PRRC).
- Provide regulatory advice to R&D, Marketing, and other departments to ensure compliance with global market requirements.
- Oversee and manage internal and external audits, including preparation, execution, and follow-up.
- Establish and maintain vendor relationships with a focus on quality standards.
- Lead CAPA (Corrective and Preventive Actions), ECRs (Engineering Change Requests), and ECNs (Engineering Change Notices) processes.
- Develop and deliver training programs on quality and regulatory requirements.
- Ensure regulated processes and systems are always inspection-ready.
- Collaborate with cross-functional teams to embed quality into product development and manufacturing processes.
- Support computer software validation (CSV) processes, including IQ/OQ/PQ protocols.
- Continuously monitor regulatory developments and ensure timely updates to internal processes and documentation.
- Maintain departmental policies, procedures, and quality documentation.
Skills & Abilities:
- Strong understanding of ISO 13485, EU MDR, USFDA, CDSCO, ICH, cGMP, and other global regulations.
- Experience hosting regulatory inspections and audits.
- Demonstrated expertise in computer software validation (CSV) and QMS implementation.
- Ability to prioritize and manage multiple projects with attention to detail.
- Strong analytical and problem-solving skills.
- Excellent written and verbal communication skills.
- Proven ability to establish and maintain strong internal and external partnerships.
- Highly independent, self-motivated, and capable of working effectively within diverse teams.
Experience:
- Minimum 2-3 years of experience in Quality Management Systems (QMS) and Regulatory Affairs (RA).
- Experience with ISO 13485, GCP (Good Clinical Practices), and related quality systems.
- Previous experience in the medical device or healthcare sector is preferred.
Education:
- Bachelor's degree in Life Sciences, Biomedical Engineering, or a related field.
- Relevant certifications in Quality Assurance or Regulatory Affairs are a plus.
Desired Skills:
- QA RA expertise
- ISO 13485 documentation and compliance
- Healthcare compliance
- QMS implementation and maintenance
- Regulatory approvals: EUMDR, USFDA, CDSCO
Why Join Us?
- Opportunity to work on cutting-edge medical technology.
- Collaborative and innovation-driven work environment.
- Career growth and professional development opportunities.
Application Deadline: 30th December 2024
Contact:
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india FLOAID MEDTECH Full timeLocation: IIT Madras Research park, Chennai, IndiaPosition Type: Quality Assurance & Regulatory Affairs (QA/RA) Specialist(Full Time)Salary: Based on ExperienceCompany OverviewWe, “Floaid Medtech” is an evolving venture aiming towards the development of cutting edge medical devices, motivated with “Make In India” vision. Our own vision is to provide...
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