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

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