Compliance

• Develop and maintain Regulatory Strategies to release and maintain product in accordance with the Standards and Regulatory requirements
• Interface with regulatory agencies such as FDA and Notified Bodies (NB)
• Provide RA leadership/support to New Product Development (NPD) teams
• Provide strategic direction on labeling, regulations, and standards
• Support the regulatory aspects of medical devices and/or diagnostic devices across a range of classifications
• Collaborate cross-functionally with R&D, manufacturing, medical, clinical, non-clinical and marketing to incorporate their reports into submissions
• Create, edit, review, and maintain regulatory submissions to support country specific marketing approval (Technical Documentation, Design Dossiers, 510(k), IDE, PMA, de novo, etc.)
• Submit and/or review PMAs/supplements/30-day notices
• Obtain approvals for new medical devices, and/or SW and/or diagnostics and determine regulatory impact of design/process changes
• Maintain product registration and review changes and registration updates as required to either regulators or NBs
• Develop, maintain, review, product labels, Instructions for Use (IFU) and any associated marketing material for compliance with applicable regulations and technical standards
• Participate in strategy development for reimbursement
• Perform gap assessments and propose remediation for regulatory submissions including technical files to EU MDR and/or IVDR
• Support International Registration Requests and coordinate device change communication to regulatory agencies across the globe as necessary
• Participate in project development teams and reviews plans, reports, risk management and design reviews associated with product and process projects intended for inclusion in regulatory submissions
• Provide acquisition due diligence and integration
• Review and provide input on clinical trials required for strategy development
• Compile/contribute to Investigational New Drug Applications (IND) and New Drug Applications (NDA)

Regulatory Affairs Consultant

Fund Compliance Analyst – US Fund Policies

Director, Privacy Compliance

Regulatory Compliance Officer – Clinical Trials

Manager, Regulatory Operations

Vice President, Regulatory Interactions