Regulatory and Clinical Affairs Consultant

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Summary

This Regulatory and Clinical Affairs Consultant is an executive leader, fluent in German and proficient in French, with over 25 years of experience in Regulatory and Clinical Affairs, leveraging extensive demonstrated success within the Medical Device/Biotech/Pharmaceutical industries to execute on worldwide regulatory submissions, implement innovative solutions, mitigate resource constraints, and elevate treatment protocols. They exhibit an unwavering commitment to quality healthcare as a results-oriented and dedicated professional, directing the planning, management, and execution of all regulatory and clinical activities to support the development of medical devices (including SaMD) and combination products, consistent with 21CFR820, IEC 62304, IEC 60601, ISO 10993, and ISO 14971. This Regulatory and Clinical Affairs Consultant has a talent for building high-performing teams, providing mentorship and regulatory guidance for all global submissions, overlapping with quality functions to provide high-quality clinical results and successful worldwide product registrations and approvals, partnering with interdisciplinary teams, ensuring regulatory compliance, and promoting market expansion efforts executed on track and on target. They have strong leadership skills and ability to effectively communicate and execute with individuals at all levels within an organization as well as worldwide regulatory agencies, clients, and customers.

Highlights

• Regulatory Submissions and Preparation
• Documentation Review
• Strategic Planning & Execution
• Medical Device Development
• SaMD
• Combination Product
• Product Registration and Approvals Worldwide
• Clinical Studies & Regulatory Compliance
• Strategic Business Development
• Internal Capacity Building
• Good Clinical Practice (GCP)
• Benefit-Risk Assessment
• Cybersecurity
• Post Market Surveillance & Vigilance
• Business Acumen

Relevant Accomplishments

• Executed the successful clearance and approval of over 35 premarket applications in the US (including PMA, 510(k), deNovo 510(k), IDE, IND, BLA, NDA).
• Responsible for EU CE Technical Files updates, approvals, and Notified Body inspections, as well as timely worldwide product approvals in all regulated markets outside of the US and EU.
• Awards for complex submission approvals and clearances, excellence in quality improvement, UDI implementation, and Boston Scientific’s first deNovo 510(k) clearance (WallFlex Biliary Stent System RMV).
• Managed an RA team of 14 across Patient Monitoring and Thermoregulation business units, optimizing clinical development timelines and shortening time to market by 40%.
• Developed regulatory plans and strategies for emerging products, engaging FDA through Q-Submissions and monthly meetings, improving clearances and approvals.
• Brought 510(k) and PMA baselines to currently fielded devices including SaMD, negotiated & agreed upon a submission roadmap with FDA regarding cybersecurity updates, opening multimillion-dollar revenue streams in the US.
• Supported cultural change within Draeger, promoting mutual respect, teamwork, and trust, driving collaboration with multidisciplinary staff on corporate initiatives and value improvement projects.
• Conducted strategic evidence planning, development, and execution on multiple research and development projects, improving time-to-market across the product line by 15%.
• Managed a team of Senior Regulatory Specialists, developing customized regulatory strategies for each product, accelerating time-to-market by reducing agency questions on submissions by 30%.
• Received several awards including WallFlex Biliary RX Benign indication expansion and the Global RA Award for Excellence in Regulatory Submissions, and cleared the first deNovo 510(k) for Boston Scientific, generating $1.2M in its first year.
• Directed cross-functional and interdisciplinary research and development project teams overseeing quality, validation, toxicology, clinical and non-clinical project stages, driving timely submissions.
• Procured approval of 11 Investigational New Drug Application (IND) amendments and 14 Clinical Trial Application (CTA) amendments, including 3 FDA meeting requests with associated briefing books.
• Coordinated and executed global submissions and re-certifications within US, CE, Japan, China, Canada, Australia, Latin America, and India markets, generating revenue streams in excess of $2M.
• Implemented strategies for timely submission and approval of pre-clinical applications, including CE Dossier approvals and FDA 510(k) clearance, improving time-to-market by 10%.

Relevant Roles

• Operations Leader
• Senior Vice President
• Vice President
• Director
• Senior Manager
• Manager
• Assistant Manager

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