SUMMARY:

• Senior medical device professional in development and licensing of electronic - mechanical & embedded software devices, drug-device combinations and digital (patient monitoring) devices; using expertise to provide support in the development of better biotech products with the vision to reduce health risks, maintain regulatory compliance and maximizing the voice of the customer by pushing the boundaries into the new or undiscovered avenues of combining science with device technology and develop more effective new diagnostic, combination and digital products.

• Develop Confidential, EU, Health Canada & international regulatory affairs & quality product strategies for Medical Devices, Combinations, Digital Medicines
• Develop, train, maintain, deploy & responsible for all elements from the Quality Management System ensuring compliance 
• Regulatory submissions - develop technical files, dossiers & submit for market clearance / approvals
• Liaise with the regulators for product development strategy, a. 30 discovery or post-submission meetings mostly TCs with Confidential and Confidential
• Technical development, engineering and author of drug-device combinations dossiers for injectables via Confidential & 510(k) combination submissions
• Design/manufacturing controls - mentored R&D & operational teams on compliance in the development of electro-mechanical devices & embedded software
• Support commercial for review & approve product marketing claims, promotional publications, digital materials, product compliance letters
• Vendors & suppliers management, technical and quality agreements, evaluation of suppliers and subcontractors, build & maintain relationships
• People management, in matrix and direct, with trust, encouragement, mentor& motivation by asking for the best of others with accountability
• Quality improvements (Kaizen & 6-sigma events); develop product risk files, Confidential, Confidential, systems, design & process risk reports
• Develop and support R&D, manufacturing & post-marketing quality trending, statistical metrics for management reviews and quarterly updates
• Plan & execute 3rd party audits for compliance as a Certified Lead Auditor; interfacing with regulatory agencies during inspections and findings
• Post-market surveillance streamline complaints, adverse events / MDR reporting, investigation to assure customers satisfaction & prevent reoccurrence

EXPERIENCE:

Confidential

Sr Manager, RA/QA Design Assurance

Responsibilities:

• Manage 4 FTEs for the global Quality Assurance & Regulatory Affairs organization, responsible for all QA & RA activities, budget and team building as well as recruitment, planning and reporting to senior management
• Provide guidance to teams on regulations, process development, design controls & engineering best practices (R&D, marketing, manufacturing, clinical & services) in the development and harmonizing the Quality Management System
• Interact with marketing to provide guidance by reviewing & providing input, approval to marketing initiatives, claims, out-going communication to customers (literature, websites, digital, paper advertisement, product forum, etc.)
• Provide product regulatory affairs and quality strategies ( Confidential, EU & Health Canada) and mentor matrix teams on the changing requirements, Regulatory Assessments (RA) and Regulatory Assessment Determination (RAD), quality design controls; serves as U.S Confidential and other regulatory agencies Point of Contact
• Manage De Novo & 510(k)-regulatory submission projects (28-Weeks Pattern & PeriWatch Vigilance) by contributing to documentation development & work with cross-functional teams in developing the technical files
• Maintain regulatory registration and served as Point of Contact for the US Confidential and notified bodies, ISO certification domestically ( Confidential ) and international markets (EU - CE Marking & Health Canada)
• Manage the Post-Market Surveillance process, complaints handling & customer support; worked cooperatively with stakeholders on complaint tool configuration, user training & launched the complaints handling tool (CRM)
• Develop product quality & regulatory statistical metrics and provide product status reporting to executive management on product quality and regulatory risks with proposed solution.
• In previous role, provided quality design QA RA oversight, including strategic planning
• Conducted periodical management reviews and facilitated various design reviews throughout project lifecycle, including product safety committee, formal phase gate design reviews, gate exit reviews, and post launch analysis.
• Advised cross-functional teams on regulatory compliance / design control developing the product scope, development plan, quality plan, risk files, document control, usability/human factor studies, verification and validation (V&V), requirement specifications and traceability
• Acting as a certified Lead Auditor, managed the internal audit program, planning & executed audits on multiple corporate sites identifying risks, non-conformities & ensure corrective action and closure
• Initiated Kaizen events for quality improvement in areas of process development, regulatory requirements, cost optimization, best practices, statistical trending & metrics for management reviews
• Worked with cross-functional teams to author, coordinate and prepare documentation for regulatory submission, ISO & TUV certification, DHF deliverables, technical files, dossiers, for 510k, PMA, CE Marking and other submissions
• Oversaw design for manufacturing ( Confidential ); participated in contract manufacturing selection (CMO), quality evaluation, inspection and incoming materials management system developed manufacturing metrics
• Managed the CAPAs and the risk management teams, conducted risk assessments including risk plan, hazard analysis, design & process Confidential, risk index & reports to the Confidential, FTA, Confidential methodologies
• Reviewed & approved product design and developed product trending and metrics reporting to executive management.

Confidential, Thousand Oaks, CA

Principal Engineer

Responsibilities:

• Executed device technical leadership and collaborated with drug development, packaging, engineering, marketing, QA, medical, regulatory affairs, supplier quality, sourcing, and manufacturing providing SME guidance in systems integration, risks identification, controls, mitigation in product submission & remediation
• Worked cooperatively with RA in the development regulatory strategy (Combination Products), the dossiers and documentation package for Confidential & 510(k) for drug-device packages including Neupogen, Epogen, Enbrel, Neulasta and responded to HA queries from Confidential and Confidential
• Managed the systems risk engineering team (6 FTEs) and owned the product risk management activities; developed corporate risk strategy, planning, and monitoring of product risks in pre-market and post-market launch
• Interfaced with programs to develop risk deliverable schedule, allocating resource and track risk assessment execution for commercial readiness and clinical studies
• Performed trade-off studies and developed use cases for development of systems requirements specifications
• Managed projects to develop the risk plan, risk management file, hazard analysis, user risk (PrHA), system risk, process risk ( Confidential ), design risk, implemented Fault Tree Analysis (FTA), and developed risk summary reports in compliant to ISO 14971 and Confidential ’s SOPs
• Served as Confidential communication Point of Contact for matters relating to product risks and led the risk team for projects in remediation; maintained & updated QMS SOPs, WIPS for processes relating to systems risk
• Chaired risk monitoring during product development, testing, and post market commercialization and approved program deliverables.

Confidential, San Diego, CA

Quality Lead

Responsibilities:

• Managed the quality programs (infusion pumps & prefilled drugs) through the development of regulatory affairs & quality strategies, to ensure product quality, patient safety, customer satisfaction, and reliability
• Provided RA/QA oversight to product development and manufacturing on matters pertained to regulatory compliance, quality design controls throughout product lifecycle
• Interfaced with regulatory agencies & acted as business representative in audit and product submission
• Authored, coordinated & managed regulatory submission projects in the development of documentation package & activities for IV drug infusion pump DHF, technical files, dossiers (NDA, Confidential, 510k, IDE & PMA) & site registration
• Led internal audits as a Lead Auditor in planning, audit team management, audit execution, findings
• Further process improvement through the development & maintenance of QMS standard operating procedures, work instruction, templates/forms with cross-functional team collaboration; Initiated six-sigma and kaizen events
• Provided council to team on requirements engineering, prototyping, sampling, test protocols development & V&V strategy, validation of software tools, process, and validation studies
• Led management reviews, phase-gate exits DHF audit & participated in design reviews.

Confidential, Boston, MA

Quality Lead Engineer

Responsibilities:

• Functioned as a Quality Site Leader; provided quality oversight to R&D and manufacturing teams and collaborated with global teams to develop and maintain quality policies and corporate QMS
• Worked with Regulatory to provide input into product regulatory & quality strategies; files reviewed and provided input for design controls compliance in product regulatory submission of 2 x special 510(k)s (imaging devices)
• Developed the quality playbook (listing of all required deliverables, ownership, risks and proposed mitigation, resources, constraints, and high-level project scheduled milestones/timeline) supporting product phase development
• Provided global oversight on SW tools and process validation in planning activities, developing strategy and process

Confidential, Carlsbad, CA

Manager, Quality Assurance.

Responsibilities:

• Directed a team (10 FTEs + 2 contractors) of verification and validation engineers and implemented IQ, OQ, and PQ via V&V operational processes to test products, and administered development tools ( Confidential and Rational ClearQuest)
• Supervised product test projects and developed test scheduling, resources, budget, planning & test strategy including new V&V protocols, test cases development & execution and product stability reports
• Spearheaded methodology for defect management and worked closely with engineering to identify and verify fixes
• Performed SW tools & process validation and led development of test automation.