Job
Description
As a Regulatory Specialist at Cyient Ltd, you will play a crucial role in ensuring compliance with regulatory requirements for medical devices, with a primary focus on EUMDR SaMD. Your responsibilities will include: - Interpreting and applying EUMDR Regulations, specifically for Desktop applications, for both new and existing products. - Preparing and submitting regulatory documentation such as EUMDR submissions, Design Dossiers, and Technical Files to regulatory authorities. - Acting as a key regulatory liaison with internal cross-functional teams throughout the product lifecycle, including R&D, Quality, Engineering, and Marketing. - Conducting regulatory assessments and offering guidance on regulatory strategies for product development and market access. - Monitoring changes in medical device regulations and industry standards to assess their impact on company products and operations. - Participating in internal and external audits, supporting regulatory inspections, and ensuring compliance with quality system requirements. - Developing and maintaining regulatory files and databases to ensure accuracy and accessibility of critical information. - Assisting in resolving regulatory issues and inquiries from regulatory bodies. - Contributing to the development and enhancement of internal regulatory processes and procedures. To qualify for this role, you should have: - A Bachelor's degree in a scientific, engineering, or related field. - A minimum of 12+ years of experience in regulatory affairs within the medical device industry. - In-depth knowledge and practical application of EUMDR and FDA Medical Device Regulations, including EUMDR Regulations, 21 CFR Part 820, and the 510(k) process. - Strong understanding of global Medical Device Regulations such as EU MDR/IVDR and Health Canada. - Proven ability to work effectively in a Cross-Functional Teamwork environment, collaborating with diverse stakeholders. - Demonstrated experience in ensuring Regulatory Compliance for medical devices. - Excellent written and verbal communication skills, with the ability to clearly articulate complex regulatory requirements. - Strong analytical and problem-solving abilities. - Detail-oriented with strong organizational skills and the ability to manage multiple projects simultaneously. As a Regulatory Specialist at Cyient Ltd, you will play a crucial role in ensuring compliance with regulatory requirements for medical devices, with a primary focus on EUMDR SaMD. Your responsibilities will include: - Interpreting and applying EUMDR Regulations, specifically for Desktop applications, for both new and existing products. - Preparing and submitting regulatory documentation such as EUMDR submissions, Design Dossiers, and Technical Files to regulatory authorities. - Acting as a key regulatory liaison with internal cross-functional teams throughout the product lifecycle, including R&D, Quality, Engineering, and Marketing. - Conducting regulatory assessments and offering guidance on regulatory strategies for product development and market access. - Monitoring changes in medical device regulations and industry standards to assess their impact on company products and operations. - Participating in internal and external audits, supporting regulatory inspections, and ensuring compliance with quality system requirements. - Developing and maintaining regulatory files and databases to ensure accuracy and accessibility of critical information. - Assisting in resolving regulatory issues and inquiries from regulatory bodies. - Contributing to the development and enhancement of internal regulatory processes and procedures. To qualify for this role, you should have: - A Bachelor's degree in a scientific, engineering, or related field. - A minimum of 12+ years of experience in regulatory affairs within the medical device industry. - In-depth knowledge and practical application of EUMDR and FDA Medical Device Regulations, including EUMDR Regulations, 21 CFR Part 820, and the 510(k) process. - Strong understanding of global Medical Device Regulations such as EU MDR/IVDR and Health Canada. - Proven ability to work effectively in a Cross-Functional Teamwork environment, collaborating with diverse stakeholders. - Demonstrated experience in ensuring Regulatory Compliance for medical devices. - Excellent written and verbal communication skills, with the ability to clearly articulate complex regulatory requirements. - Strong analytical and problem-solving abilities. - Detail-oriented with strong organizational skills and the ability to manage multiple projects simultaneously.
