Regulatory and Clinical Affairs Consultant

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
• Strategic Planning & Execution
• Medical Device Development
• Product Registration and Approvals Worldwide
• Clinical Studies & Regulatory Compliance
• Benefit-Risk Assessment
• Cybersecurity
• Leadership
• Developing High-Performing Teams
• Quality Improvement Metrics

Relevant Accomplishments

• Executed the successful clearance and approval of over 35 premarket applications in the US (includingPMA, 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.
• Served on the leadership team and engaged in all strategic decision making
• Participated in forming multimillion-dollar strategic alliances (Sibel Health, Medtronic, and others)
• Optimized clinical development timelines, shortening time to market
• Executed regulatory strategies, leveraging extensive therapeutic and medical device knowledge
• Supported successful stakeholder and patient outcomes
• Experienced rapid career advancement from Director of Regulatory Affairs to Senior Director within two years
• Managed an RA team of 14 across Patient Monitoring and Thermoregulation business units
• Managed allocated projects with a focus on efficient and timely submission approvals and clearances
• Demonstrated best practices for documentation change control reviews consistent with 21CFR820, IEC 62304, IEC 60601, and ISO 14971
• Developed regulatory plans and strategies for emerging products
• Engaged with FDA through Q-Submissions and monthly meetings, as well as regular meetings with Notified Bodies and other worldwide agencies, improving timely clearances and approvals by 40%
• Brought 510(k) and PMA baselines to currently fielded devices including SaMD
• Negotiated and agreed upon a submission roadmap with FDA regarding cybersecurity updates
• Allowed continued commercialization and opened multimillion-dollar revenue streams in the US
• Maintained Patient Monitoring and Thermoregulation device revenue streams by governing all worldwide device registrations, ensuring market access to all markets
• Strong advocate for supporting cultural change within Draeger, promoting timely market approvals through mutual respect, teamwork, and trust
• Drove collaboration with multidisciplinary staff on Corporate Initiatives and Value Improvement projects
• Developed a 510(k) Blueprint and RIM system across the organization, accelerating time-to-market of product approvals by 20-50%
• Responsible for regulatory submissions worldwide
• Guided the execution of device development, ensuring complete and accurate supportive documentation
• Successfully commercialized multiple product lines including dilatation balloons, polypectomy, pre-filled syringes, papillotomes, dilatation and stents, consistent with 21CFR820, IEC 62304, IEC 60601, ISO 10993, and ISO 14971
• Served on multiple Corporate Initiatives and Value Improvement projects, advising on best practices for 510(k)s and IDEs
• Conducted strategic evidence planning, development, and execution on multiple research and development projects including WallFlex Biliary Stents
• Leveraged keen understanding of market needs while uncovering and mitigating potential regulatory risks, improving time-to-market across the product line by 15%
• Promoted synergy between research and project teams
• Managed a team of Senior Regulatory Specialists, developing customized regulatory strategies for each product
• Optimized pathways for approval of medical devices, leveraging best practices across the business unit and organization
• Accelerated time-to-market by reducing agency questions on submissions by 30%
• WallFlex Biliary RX Benign indication expansion at NTC Boston in 2016
• Global RA Award for Excellence in Regulatory Submissions in 2017
• Clearing the first deNovo 510(k) for Boston Scientific, generating $1.2M in revenue in its first year
• Served in an integral and diversified role, overseeing functional teams
• Developed and implemented regulatory/commercial strategy for Antibody and Hormone Drug product line submissions
• Instituted a benefits/risk management plan for product submissions
• Directed cross-functional and interdisciplinary research and development project teams overseeing quality, validation, toxicology, clinical and non-clinical project stages.
• Procured approval of 11 Investigational New Drug Application (IND) amendments, 14 Clinical Trial Application (CTA) amendments, Submissions in Common Technical Document (CTD) and electronic Common Technical Document (eCTD) format, and 3 FDA meeting requests with associated briefing books.
• Managed all aspects of regulatory affairs, ensuring strict compliance with quality and regulatory protocols throughout design, development, and commercialization processes.
• Supported and executed global regulatory submissions to maintain and develop catheter and Guide Wire product lines.
• Coordinated and executed global submissions and re-certifications in the 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, FDA 510(k) clearance for the 6F Export® AP Aspiration Catheter, 6F Taiga Guide Catheters, Japan Shonin approval of Cougar® Guide Wires, Export® XT Aspiration Catheters, Sherpa Guide Catheters, and improving time-to-market by 10%.

Roles

• Head of Regulatory Affairs
• Senior Manager
• Contractor
• Regulatory Affairs Manager

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