Main point of contact for the Gene Sequencing Division's advertising and promotional review. Products are class 3 molecular IVDs and Research Use Only (RUO) products.

Specializing in regulatory review of Advertising and Promotional materials for the Acute Therapies business unit. • Acute Therapies is the largest business unit at Baxter with a mix of Class 2 medical devices and drug solutions. including Baxter's first IVD product.• Review of Emergency Use (EUA) devices and drugs. • Review of several high visibility 510k-pending product launches. • Winner of Ignite Team Award for successful product launch resulting in first sale within 1 hour of launch. • Act as point of contact for Marketing, Legal and Medical as it pertains to Acute Therapies. • Active role in development and rollout of PromoMats, act as point of contact for the Americas region as it pertains to PromoMats.

Promoted to Senior Manager RA, specializing in Advertising and Promotions (Ad/Prom) and providing second level support to global RA team of ~220 people. -Recognized with 2016 CEO Award for originating and implementing a labeling process improvement that will save ~4.6M annually. -Recognized as the single point of contact for Ad/Prom for GE Healthcare’s medical device businesses. As point of contact, manage the internal resources, answer questions, provide materials, training, data analysis, problem solve and resolve issues as presented by Legal, Marketing and RA. -Manage a virtual global team of 20 Regulatory Affairs leaders with focus on improving global review of ad/prom. This is a new approach and process is created from scratch.-Responsible for the update and management of the Ad/Prom Policy at GE Healthcare, including developing training given to approx. 3,300 employees.-Produce a Regulatory Affairs Intelligence Newsletter with 1200 recipients.-Organize monthly trainings on top of mind RA topics, attended by ~50/100 people.-Own, update and distribute several RA Requirements documents used by global RA team, engineering and marketing on a regular basis.-Zinc Ahead Super User. Key resource in development and deployment of Zinc Maps to GE Healthcare.-Headed several cross functional FDA guidance commenting opportunities on Social Media. -Conduct and participate in internal and external audits.-Daily interaction with Executive level management.-Represent GE Healthcare on the AdvaMed Ad Prom Working Group.

Promoted to Regulatory Affairs Manager specializing in Advertising and Promotions (Ad/Prom).

Specializing in Advertising and Promotions for GE Healthcare IT’s (HCIT) products and services:-Create and implement the regulatory Ad/Prom review process from scratch in HCIT. Process involves advanced relationship building skills with marketing and legal. -Provide RA input and training in area of product claims, product roadmaps, disclaimers, proper wording and approval process on marketing materials for use in tradeshows, user groups, press releases, brochures, product launches, websites and social media.-Co-wrote policies including the global Advertising and Promotion Policy and HCIT’s Social Media Policy.-Decision making responsibility on material to be shared with customers and how it is presented.Also, act as core member on development teams, providing feedback throughout the product development cycle for Radiology software products (PACS, RIS and Cardiology). Products are Class 1 and 2 and located in 147 countries:- Develop and implement a global regulatory strategy. - Provide input on design documentation including: integrated design plans, system design architecture, V&V, labeling, milestone reviews. - Evaluate proposed changes to products; develop, approve and implement regulatory plans based on changes.- Conduct internal audits and particiapte in internal and external audits. - Aid in preparation of submissions for 510(K), CE Mark, China registrations. - Maintain effectiveness of the Quality System.

Post Market Experience:- One of initial team members involved in ramping up Product Surveillance team for HCIT. - Involved in rollout of Complaint Handling Procedure and startup of cross functional review teams.- Responsible for processing, investigating, disposition of customer complaints and escalation of adverse events.-Cross trained in Field Modification Instructions (FMIs) due to recalls. Provide review and approval of FMI documentation presented in audits.

Key Accomplishments:- Create a proposal process from scratch for the HCIT business of GE Healthcare. The process was recognized as a best practice and duplicated in other parts of the company. - Supervise 3-4 Proposal Specialists.- Negotiated to reduce cost of RFP binders by 78%.- Moved printing process to an on-demand print service that dropped production time 75%.- Built database of boilerplate responses using Pragmatech software enabling RFPs to be completed 50% faster.-Interviewed, hired and trained productive, professional, motivated Proposal Specialists that helped establish integrity and trust throughout the sales force.-Personally worked on high profile, complicated RFPs including government RFPs, that we won, generating several millions in revenue for the company.

- Prepared Request for Proposals (RFPs) for Consulting Services.

- Promoted to Document Consultant preparing Request for Proposals (RFPs) for the disaster recovery business.- Worked as a Contract Specialist for large accounts including Alcoa and SCI. Position involved customer contact.