Regulatory Affairs Director

Purpose

Responsible for regulatory affairs activities such as regulatory submissions, registrations and listings. Assure compliance with applicable medical device regulations per jurisdiction, guidance and standards. Assist in creation and maintenance of regulatory files. Assist with post-market activities.

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 device submissions in USA, Europe and other countries. 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 510(k)s, medical device licenses, certificates, and CE Technical Files 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 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.
• Other duties as assigned