About Us:
At IF MedTech, we are dedicated to revolutionizing healthcare through cutting-edge medical device design, development, and pilot manufacturing. Our global team collaborates with experts across medical, engineering, business, and research domains to bring innovative solutions that enhance healthcare and improve lives. Join us in our mission to drive innovation and make a global impact in the medical technology sector.
Responsibilities:
1.) Quality Assurance:
• Establishing, verifying and maintaining Software Quality Management System (QMS).
• Develop and implement the Quality Management System (QMS) in line with ISO 13485, IMDR, 2017 and FDA QSR.
• Create and maintain quality manuals, procedures, and work instructions.
• Ensure the QMS covers all aspects of product development, manufacturing, and post-market activities other activities related to QMS:
• Plan and conduct internal audits to verify QMS compliance with regulatory standards (ISO 13485, FDA, IMDR). Prepare for external audits (e.g., by Notified Bodies, FDA, CDSCO).
• Manage supplier non-conformances and work with them to resolve issues in a timely manner.
• Manage post-market surveillance activities to monitor product performance and safety once the product is on the market. Report adverse events to regulatory authorities as required (e.g., MDR, Vigilance Reporting).
• Develop and conduct training programs for employees on quality assurance procedures, regulatory requirements, and compliance standards.
2.) Regulatory Affairs:
• Oversee design control processes and ensure they meet regulatory standards.
• Ensure traceability from design inputs to design outputs and validation.
• Lead risk management activities, ensuring compliance with ISO 14971 (Risk Management for Medical Devices).
• Conduct risk assessments and failure mode and effects analysis (FMEA) during product design and manufacturing.
• Update risk management files throughout the product lifecycle, ensuring proper risk mitigation strategies are in place.
• Ensure all validation and verification activities (e.g., biocompatibility, electrical safety, software validation) comply with regulatory requirements.
• Work closely with engineering and testing teams to review and approve validation reports before submission to regulatory bodies.
• Collaborate with cross-functional teams (R&D, Manufacturing, Marketing) to develop regulatory strategies for new medical devices.
• Identify applicable regulatory requirements in target markets
• Plan regulatory submissions for product approval and clearance.
• Liaise with regulatory authorities and respond to queries to facilitate product registration
• Compile technical documentation, including design files, clinical evaluations, and safety testing reports for regulatory submission.
Qualifications:
• 2-4 years of experience in Quality Assurance roles in the medical device industry.
• Knowledge of ISO 13485, IMDR 2017, FDA QSR, EU MDR/IVDR and other global regulatory requirements.
• Has filled at least one application as per Indian Medical Device Rule, 2017.
• Excellent understanding of product development lifecycle in the medical device industry.
• Certified internal auditor as per ISO 13485.
• Demonstrated problem-solving abilities and a proactive approach to regulatory and technical challenges.
• Strong interpersonal skills and the ability to work effectively in a collaborative, multidisciplinary team environment.
• Commitment to quality, safety and compliance in all aspects of work.
• Strong attention to detail and analytical skills.
• Joining within 10 days
Join IF MedTech to drive innovation in healthcare technology and develop software solutions that transform lives worldwide.