Regulatory Executive
2 Years +
Responsibilities
- Write, analyse, 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, Europe and other Countries. Work with other departments and communicate the submission requirements when documents are needed for regulatory submission.
- Maintenance of QMS / ISO 13485 documentations – Preparing and maintaining Quality Manuals and Procedures.
- Maintain regulatory files. Maintain and update regulatory authorizations, such as IDEs, 510(k)s, Canadian medical device licenses, and CE dossiers for EU, NRTL certifications 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 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.
- Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance.
- Assist in preparing clinical trial site ethics review board applications for investigational device trials. Prepare interim or final reports for trial site ethics boards as required.
Education
- B Tech
