Regulatory affairs specialist

This role specializes in the creation and maintenance of Instructions for Use (IFUs), risk management files, and technical files, ensuring compliance with applicable global regulations and standards. This position requires a strong understanding of regulatory requirements and a meticulous approach to documentation.
* IFU Management: Develop, write, and maintain |(including printing &translation management) IFUs for legacy devices, ensuring accuracy, clarity, and compliance with relevant regulations and standards (e.g., MDR, 21 CFR Part 801). Manage the IFU lifecycle, including revisions, approvals, and distribution.
* Risk Management File Maintenance: Maintain and update risk management files, ensuring compliance with ISO 14971. Collaborate with cross-functional teams to identify hazards, assess risks, and implement risk controls.
* Technical File Maintenance: Compile and maintain technical files for legacy devices, ensuring all required documentation is complete, accurate, and readily accessible for regulatory submissions and audits.
* Regulatory Submissions: Support the preparation and submission of regulatory documents, as needed.
*  Regulatory Compliance: Monitor and interpret relevant regulations and guidance documents, ensuring ongoing compliance.
* Collaboration: Work closely with cross-functional teams (e.g., engineering, product management, marketing) to gather information and ensure alignment on regulatory requirements.
*  Communication: Communicate effectively with internal stakeholders and external regulatory agencies, as needed.
* Audits: Support internal and external audits
* Continuous Improvement: Contribute to the continuous improvement of regulatory processes and procedures.