Engagement Partner, Quality and Regulatory Affairs

• Feb 2017 - Present

The Bruder Consulting & Venture Group (www.bruderconsulting.com) provides services to start-up through multi-national conglomerate medical device, regenerative medicine and biotechnology companies, investment banks, venture partners and private equity firms. The company’s dedicated team of executive Engagement Partners offers clients a diversified expertise in technology, product and market development, clinical and regulatory affairs, reimbursement and health economics, and commercialization strategy, including financial and/or strategic partnering. Agreements with exceptional “Affiliate Firms” that provide complimentary services to the Group, such as laboratory and animal studies for regulatory approval, global clinical trial execution, and intellectual property analysis and valuation, along with a set of world renown "Special Advisors" from academia, distinguish the Group from more traditional boutique consulting firms. Clients include companies in the United States, Europe, Israel, China, and Japan.

Founder and Principal Consultant

• Jan 2020 - Present

Director of Compliance and Regulatory Affairs

• May 2017 - Jan 2020

TranS1 is a medical device company focused on developing innovative minimally invasive spinal solutions. At TranS1 my core activities include: • Leader of Quality, Regulatory and Healthcare Compliance functions for small spinal medical device manufacturer • Develop and implement regulatory strategy for new and modified products (US (Class I/II/III 510(k)) • Serve as Management Representative and report across functional teams and levels of leadership to ensure FDA requirements are established and maintained, including (but not limited to): audits (internal and supplier), CAPA, document and record control, design control, management review, NCR, purchasing and receiving controls, risk management, sterilization/cleaning, and post-market surveillance. • Responsible for Healthcare Compliance-related issues including CMS Open Payments • Manage regulatory inspections and resolve 483 QMS nonconformities

Sr. Regulatory Affairs Specialist

• Nov 2014 - May 2017

• Provide global regulatory affairs leadership for medical device company in the spinal implant and surgical tool space, including Class I instruments and Class II/Class III implantable devices • Create and manage regulatory filings for the US, including 510(k) filings and product line extensions • Create and maintain EU Design Technical Files for Class I, IIa and IIb medical devices. • Responsible for post market safety (MDR, MDV) decisions, participate in recall decisions (Health hazard evaluation and correction/removal) and establishment registration and device listing. • Develop regulatory strategy for new and modified products and advise Executive and Product Development teams • Create technical files/design dossiers and regulatory submissions for international markets including Brazil, China, Mexico, India, and various Latin American countries. • Work cross-functionally with Engineering design teams on new products and product change requests • Participate in risk management and product validation activities. • Review and approve marketing literature/labeling and claims materials for label compliance and substantiation • SME for product complaints and post-market reporting requirements in US and internationally (MDR/MPR/Vigilance reports) • Consult for Healthcare Compliance-related issues including CMS Open Payments, HCP contracting, aggregate spend reporting (Sunshine law) • Maintains and promotes professional and productive working relationships with industry leaders, medical professionals, and colleagues at all levels.

Regulatory Project Manager

• Jun 2009 - Sep 2014

•Creation/coordination of regulatory filings for the US (e.g. 510(k), pre-IDE). •Create and manage regulatory submissions registrations in active countries worldwide including significant change requests, line extension filings, and modifications dictated by changing regulations •Report on post-market responsibilities to each market including post market safety (MDR, MDV), recall decisions (Health hazard evaluation and correction/removal) and establishment registration and device listing. •Lead Regulatory process improvement initiatives that may result from CAPA processes or internal/external audits. •Regulatory team representative on product-specific teams. •Conduct comprehensive internal compliance process audits for: Healthcare compliance topics such as HCP contracting, Quality system requirements per FDA and ISO such as Design Control, CAPA, etc. •Host audits conducted by external agencies (ISO, FDA, etc.). •Determine regulatory strategy for specific projects. •Audit Design History Files to verify compliance with Design Control procedures and regulations. •Participate in risk management and product validation activities. •Participate in healthcare compliance activities including field observations, training, document and process audits, and annual corporate integrity agreement reporting. Participate in aggregate spend reporting (Sunshine law) •Monitors post-market experience in published literature •Assumes principal responsibility for the quality, integrity and timeliness of assigned projects in accordance with established quality standards and Company SOPs •Maintains and promotes professional and productive working relationships with industry leaders, surgeons, medical facility staff and company personnel at all levels. •Assumes principal responsibility for the efficient, secure, accurate and compliant delivery of project results and reports

Quality Assurance Director/Regulatory Affairs Specialist

• 2000 - 2007

• Responsible for maintaining quality systems within company• Direct sub-groups consisting of approximately 20 individuals, including overseeing and consulting cGMP laboratory document review and approval, client report generation, review and approval, document generation and control, and client audits• Solely responsible for hosting and responding to client audits, including touring clients through facility and answering all quality-related and technical questions• Responsible for auditing and approving use of sub-contract facilities• Solely responsible for preparing company for and hosting FDA and other regulatory inspections• Perform company-wide training for major quality-related disciplines, including upper-level management FDA preparedness training and Quality Manual training for laboratories• Write, revise and monitor company documents and SOPs to maintain their applicability to current GMPs and industry standards• Perform quality system gap analysis to determine management action items• Analyze CAPA systems and consult with laboratory during root cause analysis• Developed and implemented systems to convert existing R&D chemical synthesis laboratory into cGMP environment, including developing/implementing systemd for raw and finished material receipt and control, facility requirements, batch record generation, review and approval and control, technology transfer, vendor auditing, packaging control and labeling• Perform laboratory document review and approval, including review for cGMPs and technical accuracy• Review extensive laboratory projects for method development and validation, and write development/validation reports• Review material characterization projects, and draft and approve reports• Review various analytical disciplines including HPLC, GC, dissolution, FT-IR, UV-Vis, DSC, ICP, Karl Fischer, gravimetric determinations, elemental analysis, etc.• Write and review company SOPs to maintin technical accuracy and cGMP applicability

Chemist

• 1998 - 2000

Responsible for setting up chromatography laboratory at company inception, including ordering GC and HPLC systems and writing associated operation, training, calibration and quality SOPs• Perform analytical method development and validation for raw materials and finished products, and responsible for drafting client summaries and reports• Perform various analytical desiciplines for client projects, including HPLC, GC, dissolution, FT-IR, UV-Vis, wet chemistry techniques, gravimetric determinations, elemental analysis, etc

Assistant Scientist

• 1996 - 1998

• Perform analysitcal chemistry in support of manufacturing division • Perform method development and validation for raw materials and finished products • Techniques performed include HPLC, GC, dissolution, F-IR, UV-Vis, and various wet chemistry techniques • Perform cGMP review of laboratory data for compliance • Perform analysitcal chemistry in support of manufacturing division • Perform method development and validation for raw materials and finished products • Techniques performed include HPLC, GC, dissolution, F-IR, UV-Vis, and various wet chemistry techniques • Perform cGMP review of laboratory data for compliance