Medpoint, LLC · 1 week ago
Regulatory Affairs Specialist - Contract Work - US Based
South Carolina, United States
Contract
Onsite
Mid LevelMedpoint, LLC is seeking a Regulatory Affairs expert to support the oversight of regulatory matters and strategy implementation. The role involves ensuring compliance with medical device regulations and preparing regulatory submissions, among other responsibilities.
Health Care
Hiring Manager
Gina Rivard
Responsibilities
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
Qualification
Required
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
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
Company
Medpoint, LLC
Medpoint provides medical device, diagnostic, and biopharma clients with services actively supporting domestic and international quality assurance, regulatory affairs, clinical affairs, technical engineering, and business consulting.
Founded in 2002
11-50 employees
Funding
Current Stage
Early StageLeadership Team
D
David E. Orr
Chief Executive Officer
Recent News
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