Niramai is looking for an experienced dynamic professional who will be responsible for regulatory affairs activities to assist in regulatory submissions, annual reports, registrations and listings. Assure compliance with applicable medical device regulations per jurisdiction, guidance and standards. Assist in creation and maintenance of regulatory files.
Primary Roles & Responsibilities:
- Write, analyze, and edit technical documents to support country specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents, including investigational device submissions in USA and Europe. Work with other departments and communicate the submission requirements when documents are needed for regulatory submission.
- Maintain regulatory files. Maintain and update regulatory authorizations, such as IDEs, 510(k)s, PMAs, MDSAP countries medical device licenses, and CE dossiers for EU etc. Assure that appropriate maintenance of registrations occurs including renewals, device listings, site registrations, supplements for changes and annual reports. Support approval in other regions as required.
- Assist in preparing response to regulatory authorities questions within assigned timelines.
- Stay abreast of regulatory procedures and changes in regulatory climate.
- Assess device related incidents/complaints for medical device reporting requirements. Compile and submit reportable events to relevant regulatory authorities in a timely manner. Handle recalls and field actions, if required.
- Review and create product labels and review promotional material for compliance with applicable regulations and technical standards.
- Hands-on experience in Medical device Regulation transition (MDD to MDR).
- Experience in regulatory affairs of SaMD ( Software As Medical Device) preferable.
- Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance.
- Experience: Minimum 3-4 years of experience in Medical device Regulatory.
- Education: Bachelor’s degree in science/biomedical/engineering.
|Job Category||Quality Assurance & Regulatory Affairs|