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Regulatory Compliance Specialist

2 months ago

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

The Regulatory Affairs Specialist will play a crucial role in overseeing compliance and implementing strategies to ensure that Medpoint, LLC adheres 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, guidelines, and standards applicable to the markets where products are sold. Additionally, the role involves assisting in the creation and maintenance of documentation necessary to demonstrate adherence to medical device regulations.

KEY RESPONSIBILITIES:


• Develop, review, and refine technical documentation to support regulatory submissions tailored to specific countries, ensuring alignment with applicable guidance. Collaborate with various departments to communicate submission requirements effectively.


• Maintain comprehensive regulatory files, ensuring that regulatory authorizations, such as CE dossiers for the European Union, are current. This includes managing renewals, device listings, site registrations, and any necessary supplements or annual reports.


• Assist in formulating responses to inquiries from regulatory authorities within designated timelines.


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


• Evaluate device-related complaints to determine medical device reporting obligations. Compile and submit reportable events to the appropriate regulatory bodies punctually. Manage recalls and field actions as necessary, and review complaint files for approval.


• Support audits conducted by external regulatory agencies, providing insights to mitigate potential non-compliance findings.


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


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


• Employ problem-solving skills with a solid understanding of compliance requirements, gathering objective evidence for investigations to address issues effectively, particularly in scenarios where standardization may be lacking.