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IF MedTech Pvt Ltd | RA Officer | navi mumbai
1 month ago
At IF MedTech, we are dedicated to revolutionising 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.
Role and responsibility as RA – Regulatory Affairs Officer
Design Control & Product Development
- Oversee design control processes and ensure they meet regulatory standards.
- Ensure traceability from design inputs to design outputs and validation.
Risk Management
- 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.
Product Testing and Validation Support
- 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.
Regulatory Strategy Development, Registration and Submission
- 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 submissions
Qualifications
- 3-5 years of experience in RA roles in the medical device industry.
- Knowledge of ISO 13485, IMDR 2017, FDA QSR, EU MDR/IVDR and other global regulatory requirements.
- 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
