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Regulatory Compliance Specialist

2 months ago

Columbia, South Carolina, United States Medpoint, LLC Full time

The Regulatory Affairs Specialist at Medpoint, LLC will play a crucial role in overseeing compliance with regulatory standards and implementing strategic initiatives to ensure adherence to relevant regulations. Key responsibilities include managing regulatory submissions, registrations, and listings on a global scale. The specialist will ensure compliance with medical device regulations, guidance, and standards applicable to various jurisdictions.

KEY RESPONSIBILITIES:


• Develop, review, and refine technical documentation to support regulatory submissions tailored to specific countries, ensuring alignment with applicable guidance documents. Collaborate with cross-functional teams to gather necessary documentation for regulatory submissions.


• Maintain comprehensive regulatory files and keep regulatory authorizations up to date, including CE dossiers for the European Union. Ensure timely maintenance of registrations, including renewals, device listings, site registrations, and annual reports, while supporting approvals in other regions as necessary.


• Assist in formulating responses to inquiries from regulatory authorities, ensuring timely and accurate communication.


• Stay informed about evolving regulatory procedures, guidance documents, standards, and shifts in the regulatory landscape.


• Evaluate device-related complaints to determine medical device reporting obligations. Compile and submit necessary reports to regulatory authorities promptly, and manage recalls and field actions as required. Review and approve complaint documentation.


• Provide regulatory expertise during external audits by regulatory agencies, aiming to minimize the risk of non-compliance findings.


• Engage in post-market surveillance activities for licensed products to ensure ongoing compliance and safety.


• Establish and monitor Key Performance Indicators (KPIs) related to regulatory compliance.


• Utilize problem-solving skills with a strong understanding of compliance requirements, collecting objective evidence to support investigations and resolve issues effectively.