Regulatory Specialist

Job Summary

We are seeking a highly motivated and experienced Regulatory Specialist to join our team. In this role, you will be instrumental in ensuring Cyient Ltd's medical devices meet all relevant regulatory requirements, primarily focusing on EUMDR SaMD experience. You will collaborate closely with cross-functional teams to navigate complex regulatory landscapes and facilitate product approvals.

Job Responsibilities

Interpret and apply EUMDR Regulations, for SaMD particularly for Desktop applications for new and existing products.
Prepare and submit regulatory documentation, including EUMDR submissions, Design Dossiers, and Technical Files, to regulatory authorities.
Act as a key regulatory liaison with internal cross-functional teams (e.g., R&D, Quality, Engineering, Marketing) throughout the product lifecycle.
Conduct regulatory assessments and provide guidance on regulatory strategies for product development and market access.
Monitor changes in medical device regulations and industry standards, assessing their impact on company products and operations.
Participate in internal and external audits, supporting regulatory inspections and ensuring compliance with quality system requirements.
Develop and maintain regulatory files and databases, ensuring accuracy and accessibility of critical information.
Assist in the resolution of regulatory issues and inquiries from regulatory bodies.
Contribute to the development and improvement of internal regulatory processes and procedures.

Job Qualifications

Bachelor's degree in a scientific, engineering, or related field.
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 (e.g., EUMDR Regulations, 21 CFR Part 820, 510(k) process).
Strong understanding of global Medical Device Regulations (e.g., EU MDR/IVDR, Health Canada) is mandatory.
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 articulate complex regulatory requirements clearly.
Strong analytical and problem-solving abilities.
Detail-oriented with strong organizational skills and the ability to manage multiple projects simultaneously.