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Regulatory Affairs Specialist
2 months ago
The Regulatory Affairs Specialist works closely under direct supervision to learn and develop the regulatory skills required to bring medical devices to market and ensure ongoing compliance. Participate on cross-functional teams, develop global regulatory strategies, author regulatory submissions, interact with regulatory agencies/notified bodies, review labeling and marketing materials, and evaluate proposed device changes.
General Responsibilities:
• Work with supervision, conferring with more senior staff when indicated. Keep supervisor regularly apprised of project status.
• Participate in New Product Development Teams throughout all phases to ensure US, EU, and other international regulatory requirements are incorporated as part of the development process.
• Evaluate medical device regulations and develop strategies for bringing products to market.
• Contribute towards obtaining US and EU regulatory approvals by authoring, compiling, and submitting premarket regulatory applications.
• Partner with global regulatory affiliates and leverage Reconstructive product expertise to provide submission documentation for expedited international market access and sustaining support.
• Assess global impact of changes to launched products and support notifications/submissions as required.
• Review labeling and marketing literature for compliance with regulatory requirements.
Additional tasks may include:
• Determining and communicating submission and approval requirements
• Compiling, preparing, reviewing and submitting regulatory dossiers to authorities
• Interfacing and coordinating directly with FDA, Notified Body reviewers, and other regulatory agencies on submissions, approvals or other issues.
• Reviewing and approving change documentation for regulatory impact on launched products.
• Providing regulatory input for and appropriate follow-up to inspections and audits
• Reviewing and approving labeling, advertising and promotional items for compliance before release
• Assisting in the development, implementation, and maintenance of regulatory procedures to ensure ongoing compliance of new and existing products.
• Providing regulatory input for NCs.
• Preparing and updating US product registrations and listings
• Assisting in the establishment and maintenance of regulatory information systems both electronically and hard copy.
• Participating in process improvement activities and projects.
• Assisting in complex projects and performing delegated tasks as required.
• Assisting with product post-market or clearance requirements (progress reports, annual reports etc.)
• Assessing the acceptability of quality, preclinical and clinical documentation for submission to comply with regulatory requirements
• Identifying issues early in the submission preparation process that could impact product launch
• Communicating and negotiating with regulatory authorities and stakeholders under supervision of more experienced RA team-members.
• Ensuring project team(s) and RA management remain informed regarding all regulatory agency/Notified Body correspondence.
Minimum Requirements:
Bachelor’s degree in an Engineering, Science, or equivalent field 0-2 years in a Regulatory Affairs role#IJ
Travel Percentage: None