Lead Regulatory Engineer - Global Compliance Regulatory Affairs at Welch Allyn & Global Regulatory Affairs Operational Excellence at Hill-Rom: Continue to support all Welch Allyn prior responsibilities, in addition to newly expanded role for Hill-Rom Corporate to include: managing two additional business units (FLC & GSS) FURLS establishment registrations and device listings; lead team to establish Portal web-site across all 3 SBUs; manage CECATS for CFG's to ensure global registrations are successful & Board of Pharmacy licenses renewals and expansion for acquisition integration. Provide Regulatory NPD/ Sustaining Engineering project support ensuring product can be registered at product release to market. Lead cost saving / consolidation project to shift from TechStreet to SAI Global to bring two business units onto a single standards management tool in 2017. In 2018 lead project to bring remaining third business unit onto the same tool, thus standardizing how we work across Hill-Rom and cutting substantial costs. Lead Lithium Ion battery IATA dangerous goods project to ensure we complied with the regulation and have easy access to evidence as needed by logistics team. Built Global RA website (google) portal to easily link our people to our processes and tools, for seamless access, deployed and trained in 2016. In 2017 redesigned the Portal to work within SharePoint and redeployed for FLC. In 2018, lead project to harmonize a second business unit into a single tool. Recruited to speak at the 2017 CNY Biotech Accelerator program on Technology Commercialization.

I was recruited by the Board Chairman to join town government and subsequently appointed to the position by the Town Board. The Town Planning Board is a statutory body of Town Government tasked with developing urban plans with an aim to ensure the health, safety, convenience and general welfare of the community through the process of guiding and controlling the development and use of land and to bring about a better organized, efficient and desirable place to live and work. (2017-present) Subsequently, I was appointed to also be on the Zoning Board of Appeals, where we listen to appeals, evaluate requests for interpretations and approve or deny dimensional and use variances. (2019-present). A great opportunity to give back to my community.

As an avid outdoorsman and archer, I identified an unmet need for the archery market, solved the technical problems, obtained a patent, designed the product, built a company and currently manufacture & market a novel bow sight. The goal was to go through this entire process to answer the age old question - "how hard could it be?"

Support project teams to register products in the global market, by working closely with FDA to provide CFGs (CECATS), various documents and authentications (Apostille or embassy) to establish new Device Listings (FURLS) & updates as required. Notary Public (exp. 10/2023). Ensure that new global regulatory changes are communicated to stakeholders. Perform gap assessments to verify WA complies with the current global regulations. Initiate and lead projects (e-IFU, BP Accuracy ISO81060-1, IATA compliance, etc.) to ensure compliance to these changing regulations. Build tools (google/SharePort portal websites to provide customer self-service, Excel/SmartSheet trackers to gather & communicate request status, etc.) to ensure stakeholders have access to the information they need to be efficient at their jobs. Manage renewal of all State Board of Pharmacy licenses, yearly renewal of FDA Laser Report, FDA Establishment Registration (new & renewals), obtain GMDN codes, administer acquiring & managing standards, etc. Act as Project Manager as needed to ensure company regulatory initiatives are planned & executed as required. Reason for change: promotion.

Manage incoming customer complaints for monitoring products. Work with tech support and customer to understand the nature of the issues to determine reportability, submit MDR or provide non-report rationale. Implement and share-out standard work wherever possible. Perform failure investigations as required and provide additional information (AI) as requested from regulatory bodies. Instrumental in closing a large backlog of CAPAs, including failure investigations and communication with FDA. Reason for change: expand RA skills.

Managing a testing team to support product development teams, through managing the verification and validation program. These activities include: establishing V&V plans, managing schedules, acquiring & training resources, building test units, ensuring production equivalency, establishing assembly instructions, writing test protocols, running tests, writing test reports, motivate test team and resolving any issues to keep project on schedule. Track Quality System document change requests and work with requesters to revise procedures, gain stakeholder buy-in and final implementation. Reason for change: to gain RA skills.

Establish a process based on best practice principles (LEAN, 6 Sigma, CMMI, etc.) to enable focused & measurable improvements to be made. In the process analyst role: searching out past data, performing analysis on it and presenting to management in comprehensive package to enable decisions to be made. Manage the process improvement activities within NPD, including many changes to process documentation, forms & templates. Manage the Quality System Documents including design control process and the Gate System for consistency and compliance risk, by reviewing proposed changes and authoring / implementing as appropriate. Establish and manage the training system (& the Training Specialist) for over 150 R&D employees, improving and defining the process to allow it to franchise to other groups. SEI conference presenter, 2 years. Lead CAPA project to update the process documentation in response to FDA 483 Warning Letter / ISO observations. Earned WG Allyn Level II Award for leading this project. Promoted for the above work. Successfully lead effort to implement lean A3 with standard work product in the form of Common Test Protocol, to align all functions and sites to a single test format. Reason for change: promotion.

Establish a NPD process (Gate System overhaul) including authoring a suite of Design control procedures that is compliant to Part 820.30 design controls and Part 11 regulations for legacy systems. Lead cross-functional team to deploy the new process to all functions / sites (global), ensure users were fully functional. Extensive global travel required provide training. Lead effort to establish SW tool (lotus notes) to facilitate user compliance with the new process, while improving information sharing, traceability through requirements / design / test. Worked closely with industry experts (ex-FDA) to gain a deep understanding of the FDA / ISO regulations and how to establish a compliant / efficient system to develop safe and effective medical devices. Worked with project teams as a quality assurance representative to ensure they were fully compliant to the new quality system. Established Project Manager’s Tool Box database and coordinated monthly collaboration meeting to share best practices across project teams. To further my SolidWorks experience, I volunteered to work outside my team (spare-time) to design the new Aneroid Sphygmomanometer device (DuraShock) to reduce cost & increase durability, earned multiple patents for this new technology.

Dental SBU: Lead the Nova dental camera system development project, act as Mechanical Engineering lead and Optical Engineer to use innovative materials and designs to substantially cut the cost for a hand-held intraoral imaging system. Early adopter of SolidWorks as the design tool for Nova HW. Submitted 3 patents to cover new technology. Lead the x-ray improvement program to double production rate and increase yield (20%) of supplier, with hands on evaluation of and improvements to their mfg processes, with much time spent working at their production facility. Develop multiple, working feasibility concepts for future dental products. Contact Name Rick Tamburrino, Eng. Mgr.

Lead team to develop high end distal laparoscope based on the encore platform, acted as lead ME & Optic eng. Lead prototype team to develop flexible proximal surgical camera for Encore, Endo & Surgical SBUs with new low cost molded materials. Lead team to implement Cadra SW tool to replace discontinued Anvil. Supported early IP development of the new cost reduced sphygmomanometer (Durashock), which replaced all previous BP gauges. Supplied the dental team with injection molded hand-piece designs, that revolutionized the styling and reduced the costs for both Solo and Reveal projects. Reason for change: Promotion

Redesign LCI-200 to meet CE standards and ensure reliable manufacturability. Design & implement critical improvements to reduce cost and improve product reliability of distal-vu 360 laparoscope. Designed novel 360 deg EMI shield to meet IEC-601 specs on dental camera. Project lead to implement LCI-200 proximal laparoscope into production. Develop tools / fixtures for production needs. PE lead to support entire MIS production line. Designed courses & trained operators to assemble products. Reason for leaving: Promotion

Designed commercial equipment for non-contact measurement of rolled stock using isotope and x-ray technology. Started designing on the drafting board, but quickly lead effort to implement CAD tools (Applicon Bravo3, PTC [now Pro-E] & AutoCAD) to improve quality and efficiency of design. Managed the Hardware Engineering team. Heavy mechanical design for use in the steel, aluminum & paper rolling mill industry. US DOD Secret security clearance.