The Regulatory Affairs expert will support the oversight of regulatory matters and strategy implementation to ensure organizations comply with the applicable regulations.
Activities include regulatory submissions, registrations, and listings, globally. Assure compliance with applicable medical device regulations, guidance, and standards for jurisdictions where devices are marketed.
Assist in creating and maintaining documents required to demonstrate compliance with medical device regulations.
RESPONSIBILITIES (include but not limited to) :
Write, analyze, and edit technical documents to support country-specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents.
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 CE dossiers for the 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 responses to regulatory authorities’ questions within assigned timelines.
- Stay abreast of regulatory procedures, guidance documents, standards, and changes in regulatory climate.
- Assess device-related complaints for medical device reporting requirements. Compile and submit reportable events to relevant regulatory authorities on time.
Handle recalls and field actions, if required. Review and approve complaint files.
- Support external regulatory agency audits, providing regulatory input to minimize the potential for findings of non-compliance.
- Participate in post-market surveillance activities for licensed products.
- Establishing and maintaining Key Performance Indicators.
- Problem solving with a clear understanding of compliance requirements and the ability to collect objective evidence for investigations can help solve problems, typically in situations where general standardization should exist, but may not be operating effectively.
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The Regulatory Affairs expert will support the oversight of regulatory matters and strategy implementation to ensure organizations comply with the applicable regulations. Work with other departments and communicate the submission requirements when documents are needed for regulatory submission. Stay...
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