Nicholas Baker, Msc, Mba Email & Phone Number

Kloten, Zurich, Switzerland

Kloten, Zurich, Switzerland

Primary duties include:UDI and Regeneratives• Maintain UDI processes (e.g. GUDID) and implement additional countries UDI processes (e.g. EUDAMED), incl. monitoring of legislative UDI and medical device database requirements globally• Ensure timely and accurate UDI submissions for new launch projects• Provide in-depth knowledge and regulatory input in UDI and RA data governance projects under some guidance, including testing of new IT solutions• Support RA processes related to 3rd party regeneratives products, including products for CE, US and CA.Label and IFU• Provide regulatory subject matter expertise on global labeling and IFU (including eIFU) regulations• Provide in-depth regulatory guidance for Nobel Biocare IFU and labeling processesGeneral:• Develop and execute regulatory strategies, ensuring that near misses, nonconformities and lessons learnt are monitored and systems and procedures updated to prevent re-occurrence.• Develop and provide, under minimal supervision, regulatory guidance to project teams in terms of premarket requirements and related submission to support optimal timelines and required compliance levels• Create, review and maintain technical files.• Review and approve of product related labeling and marketing material and associated claims.• Assessment, approval and regulatory implementation of change requests under guidance and supervision.• Support internal and external audits.• Creation and maintenance of regulatory procedures and templates under guidance.• Provide internal trainings on relevant regulatory procedures and requirements.• Support standard committee work including creation of gap analyses.• Monitor closely guidelines, regulations, changes in the marketplace and regulator positions for the assigned markets.

Winterthur, Zurich, Switzerland

Primary duties included:• Lead team of product packaging and labeling development engineers• Site packaging and labeling project management with global reporting responsibility• Cross-functional IT-business program and project management

Winterthur, Zürich, Switzerland

Winterthur, Zürich, Switzerland

Carson City, Nevada

Wykle Research is a dental medical device manufacturer.• Responsible for daily operations and supply chain planning• Continuous improvement / LEAN manufacturing process development• Technical File preparation for regulatory submissions

Crucial Life Sciences Data Solutions is a Software-as-a-Service company with a flagship electronic data capture product used for clinical research. • Global business development, marketing, and product management for SaaS platform (B2C & B2B)• Digital health new product development and market introduction• Product and process integration with electronic health record platforms• Troubleshooting and customer service operations

Synvasive Technology (wholly-owned subsidiary of Zimmer Biomet) is an arthroplasty instrument medical device manufacturer. • Site development lead for new product introduction projects• Coordinated logistics of new product launch in EU• Continuous improvement / LEAN manufacturing process development• Project management with global cross-department coordination

Duties included: Lab instructor for undergraduate engineering course Numerical Methods, Instruction team assistant for Undergraduate Mechanical Engineering Capstone Design course, Graduate researcher studying alternative energy applications of PDMS-based microfluidic devices in Polymer Microsystems (PLuS) Lab.

Reno, Nevada Area

Managed project budget and contractual time constraints with United States Department of Agriculture, Business development lead for regional energy auditing program, Quantified building energy performance and calculated energy savings through site-specific upgrades, Wrote numerous technical reports outlining audit results in layman’s terms for business owners.

Reno, Nevada Area

Duties included: Led engineering team in design, construction, and instrument installation for renewable energy systems performance monitoring and control, Developed data acquisition user interface for renewable energy system data logging and control, Led presentations of renewable energy systems to groups of students and researchers.

Reno, Nevada Area

Sales specialist, including customer service, basic hardware troubleshooting, inventory control assistance, and group workshop facilitation.

Master Of Science (Msc), Mechanical Engineering, 3.7 Gpa

Thesis title: "Multifaceted Learning Objective Assessment in a Mechanical Engineering Capstone Design Course" Graduate Coursework: EE.

Master Of Business Administration - Mba, Business Administration And Management, General

Executive MBA program

Bachelor Of Science (Bsc), Mechanical Engineering, Minor In Statistics, 3.5 Gpa

Activities and Societies: Tau Beta Pi Engineering Honor Society, American Society of Mechanical Engineers student member, high school.

Associate Of Arts (A.A.), General Studies

Activities and Societies: Made Dean's list in Fall 2008, member of Phi Theta Kappa, participated in group photography/mixed media.