Diana Taylor Email & Phone Number

Boston, Ma, Us

Providing technical consulting services to Pharmaceutical, Medical Device and Healthcare companies in the US, Europe, Asia, Australia, Africa and the Americas.Offering amateur thermal imaging services & infrared surface analysis for non-diagnostic applications in the New England area. Equipment used is a FlirOne iPhone accessory which translates invisible thermal energy into dynamic color images.

Murray Hill, New Jersey, Us

Initial role focused on early project planning and management of tasks related to implementation of new European medical device requirements. Current role is focused on implementation of the clinical requirements within the European Medical Device Regulations [Regulation (EU) 2017/745 and Regulation (EU) 2017/746] for the Interventional Surgery business unit hernia mesh products as well as hemostats and surgical sealants.• Responsible for ensuring that all clinical evaluation aspects of the EU MDR are properly implemented to support an uninterrupted supply of CE Marked products to the European Union in 2020 and beyond.• Responsible for managing project timelines, generation of detailed project plans, and coordination of critical project activities to successfully establish and maintain processes compliant with FDA and EU MDR regulations. Serving to facilitate on-time or early task completion by bringing together appropriate subject matter experts from various global locations to identify and implement best practices while aligning efforts across multiple divisions.• Supporting critical CAPA project to remediate Clinical Evaluation Reports and Biological Evaluation Reports to satisfy more stringent technical documentation requirements associated with the EU MDR.• Assessed clinical data to establish and justify sufficient levels of clinical evidence for Class III products receiving CE Marking under EU MDR. Products include mesh for hernia repair, fixation devices, surgical sealants and hemostats.

Compliance Consultant – Program management role at this market leader in soft tissue repair, vascular surgery, interventional cardiology, interventional vascular, and chest drain systems was focused on managing remediation activities. Portfolio includes therapeutic devices, drug delivery coatings, and a unique bioabsorbable gel coating derived from a pharmaceutical grade (proprietary) biomaterial.• Responsible for ensuring that target dates are achieved for a remediation program with 7 distinct Work Streams affecting all product lines. Provided weekly to senior management utilizing a visual format compiled using GlidePath tool and MS Project to illustrate progress visually. • Supported critical CAPA projects including Technical File and Standards gap assessments.• Responsible for managing project timelines, generation of detailed project plans, and coordination of critical project activities to successfully establish and maintain processes compliant with FDA and EU MDR regulations. Serving to facilitate on-time or early task completion by bringing together appropriate subject matter experts from different teams to combine efforts resulting in a more streamlined and simpler process.

Marlborough, Massachusetts, Us

Responsible for utilizing appropriate regulations, standards and QMS requirements, sound engineering, manufacturing and quality principles on moderate to complex medical applications across a broad range of products& drug/treatment delivery systems for other OBLs (Own Brand Labelers). • Provided quality engineering support for new regulatory submissions, cGMP or GLP test protocols/reports, validations, clinical builds, transfers, supplier qualification & maintenance, training, regulatory submissions, Batch Records, and on-going commercial production. Provided technical support for technology transfers and manufacturing line transfers, process improvements, including the packaging of sterile devices.• Worked with external suppliers, providing technical services to ensure quality and performance objectives were met including validating process changes related to devices or tooling. Used appropriate statistical techniques to develop validation protocols, complete process capability studies and process validation on both internal and supplier processes. Utilized pFMEA/aFMEA/dFMEA tools as well as Risk Analysis tools for process development, validation and maintenance in compliance with FDA regulations and EU MDR requirements.• Developed & managed programs to assess and improve compliance of supplier services and products to domestic and international regulations.

Quincy, Ma, Us

Consulting role at a small start-up seeking regulatory approval for a specialty infusion catheter with a rotating wire tip designed for the controlled 360-degree dispersion of physician-specified agents to a targeted treatment area. Often referred to as MOCA (mechanical occlusion chemically assisted), the ClariVein® is fully disposable, minimally invasive, and can be efficiently used in an office setting. • Developed a product specification and test protocols to support FDA regulatory approval for a disposable medical device with 85 cm catheter that rotates inside human vein. • Produced design validation protocols, test method protocols, and product stability study protocols for new products and longer shelf-life claims in compliance with ISO 13485, ISO 60601, FDA 21CFR820, ISO 11607, ISTA 2A, and related ASTM Standards. Generated appropriate statistical sample size rationale/justification, data collection forms, testing flow chart, and traceable specifications/requirements to comply with GMP regulations.

Franklin, Ma, Us

Creating seamless working relationships with top clients serving patients worldwide through development and manufacturing of innovative medical devices. Tegra Medical is a premier provider of complex components and finished devices for medical device companies including rapid prototyping and Design for Manufacturability services.

New Brunswick, Nj, Us

Developing and implementing Risk Management Process alignment strategy to ensure compliance with all Ethicon Franchise procedures for new product development and post market surveillance activities across implants and dermal filler product lines.

St. Paul, Minnesota, Us

Conducting regulatory compliance audits of processes and procedures, developing & implementing corrective action plans, assisting with formal responses to FDA, managing remediation activities and aiding in audit readiness training.RABQSA Certified Quality Management System Lead Auditor conducting and managing first and second party audits. Facilitating and managing third party audits.

Watford, Hertfordshire, Gb

• Functioned as a General Manager to drive revenue for Knee and Hip franchises by turning strategy into reality. • Successfully implemented a new global launch process resulting in an unprecedented on-time US launch for the most advanced acetabular system for primary arthroplasty serving active patients. 2009 US sales exceeded $40MM. Product builds to support launch exceeded all previous launches and were in place within regions prior to the official launch, allowing surgeons to begin using product immediately. This was accomplished through superior supplier quality management, improved internal processes and new launch processes.• Managed scope, budget, time and requirements to maximize revenue growth through strategic and tactical approaches for successful launch of new global platforms through the creation of high performing launch teams involving sales, marketing, logistics, planning, operations, engineering, clinical affairs, training, compliance and distribution.

Minneapolis, Mn, Us

Facilitated strategic growth by enabling the quickest time to market for new products and line extensions for the Neurologic Technologies business within the Surgical Technologies sector. Managed extended teams of up to 25 people in critical role providing leadership to ensure quailty assurance obligations are appropriately met as well as compliance with all federal, corporate, and international regulations. Ensured that all operations associated with the development, manufacture, procurement and release of new products were performed in compliance to the QSR, ISO 13485, ISO 14971, EN 46001, CE, Japanese, Canadian and other applicable regulations. Served as a partner to R&D, manufacturing and suppliers in the development of new products and processes through active design review, sourcing and qualification, direct reliability testing, and the performance of post-market surveillance. Functioned in a quality oversight role to ensure compliance with all internal & external procedures, and to ensure user requirements are complete, accurate and satisfied through innovative designs & rapid product development.

New Brunswick, Nj, Us

Drove growth through new product development and commercialization in Cardiology as an Engineering Manager managing up to 12 technical experts directly and more than 80 people indirectly on product development teams. Collaborated with senior leadership team to ensure compliance to set quality criteria while delivering on all project commitments. Implemented new accountability methods for executing business plans to meet key performance indicators and to achieve quality, value and cost goals. Research techniques included ethnographic studies and innovation workshops to identify and develop concepts to address spoken and unspoken needs in clinics and hospitals worldwide. Managed portfolio development through cooperation utilizing cross-functional teams in multiple US & OUS locations.

Managed a rapidly growing international tehnical sales and support team driving growth at key accounts in the US and Europe with a focus on the major medical device manufacturers including Abbott Labs, Boston Scientific, Johnson & Johnson, Guidant, Medtronic, Sorin Biomedica, Jomed, etc. Negotiated, facilitated and secured long-term contracts valued at greater than $80MM with major medical accounts in the US and Europe to ensure stability & long-term revenue growth.

Abbott Park, Illinois, Us

Managed a small machine shop and provided technical support on behalf of the Corporate Engineering Division located in Chicago. Position involved technical consultation for various Abbott Laboratories facilities in the US to support new product development and sustaining engineering for existing products in areas such as diagnostics, vascular, nutritionals and hospital products. Previous positions at Abbott included positions as Technical Product Development Project Manager, Design Engineer and Manufacturing Engineer. Functioned as a Lead Auditor for 2 internal ISO audit teams and as a certified auditor on multiple ISO internal audit teams prior to ISO certification.

Abbott Park, Illinois, Us

Simultaneously managed up to 7 projects for new immunoassay system and oversaw the status of all other TPD projects. Prepared and presented status reports for management and clients, including obtainment of approvals for all project scope changes. Projects included design enhancements for mechanical and electro-mechanical systems including reagent pack opener, liquid level sensing, aspiration probe, sample carrier, liquid management system, sample detection & identification, reaction chamber design, reliability improvement projects and cost reduction projects.

Bachelor Of Science, Mechanical And Electrical Engineering

Nursing

Bachelor Of Science - Bs, Engineering