Stephanie Christianson Teague Email & Phone Number

Iselin, New Jersey, Us

- Global team leader with for Regulatory Affairs and Product Safety for the Global PPE BU- integration leader for the acquisition of Kimberly-Clark Professional PPE by Ansell - Drive regulatory and strategies, submissions, ad/promo reviews, Functional global leader of the BU for Regulatiry- Global RA transition and integration leader as part of the KBU vertical- Prepare and share of North American submissions for KBU gloves - Develop and report out RA and Product Safety Transition and Integration KPIs- RA resourcing and capability building- Optimize KBU RA and PS processes in support of the integration - Work in a fast paced environment meeting key product deliverables including regulatory audit support, submissions, ad/promo review, design control

Irving, Tx, Us

KCP Global PPE Team Leader for Regulatory Affairs and Product Safety.

Irving, Tx, Us

North American regulatory manager for gloves for Kimberly-Clark Professional.

Durham, Nc, Us

* Regulatory and Technical lead for a Class III Hyaluronic Acid product and Breakthrough Device for cartilage repair * Key Responsibilities include: PMA support for evaluation of changes, PMA supplement filings, Annual Reports, and Post Market Study Reports * Carries out US, Canada and OUS registrations across the Bioventus portfolio* Serves as US Agent and FDA point of contact * Develops and leads regulatory strategy amongst cross-functional team environments* Design and development activities supporting new products * Core Audit team member for QMS, EU MDR, and Supplier Audits * EU MDR key team leader

Alpharetta, Georgia, Us

* SME in UDI, Technical Files and documentation, EU MDR, UK CA marking and PPE Regulation across a variety of product platforms* 510(k) and Canadian license contributor across a variety of product lines * Successfully led and managed EU MDR preparedness including gap analysis, procedure development and technical documentation creation* Deployed new standards review program enterprise wide* Manages CE/CA marking process and products for Global Products Division: procedure development and maintenance, ERC/GSPR/EHSR, Technical File/Document, Declarations of Conformity, and maintenance of all CE/UK CA certificates *UK CA marking SME and primary regulatory strategist*Regulatory Corporate liaison with Notified Body * Corporate liaison for standards groups: AAMI & ASTM and active participant in working groups * Regulatory Audit management and designated support resource (FDA, Notified Body, Customer Supplier Audit, NIOSH, MDSAP, and PPE)* Designated Representative and State Licensure with Board of Pharmacy * Current member of MedTech Europe – EUDAMED Working Group AAMI primary voter for ST-WG-03 and ST-WG-40* Designated regulatory personnel for all technical data, procedures and analysis – including documentation for clinical literature search, plans, and evaluations *Monitors and maintains relevant standards to support medical devices class I-III and PPE products Category I-III in multiple markets including North America, Europe, Asia Pacific and Latin America

Develop research projects in the microvascular fieldCreated HPLC methodology for superoxide production in microvascular disease in patients with known metabolic syndromesObtain grant funding from government and private funding sources sourcesResponsible for purchasing and procurement for the laboratoryParticipate in a multi-center clinical trials including drug in vivo drug studies for heart failure with preserved ejection fraction (HFpEF)Researcher in multi-center cohort study involving assessment of peri-operative heart tissue and post mortem brain tissue and superoxide production Strong background in IRB processes for research studies Research scientist for several clinical trials for screening and drug discovery

• Managed experienced addiction specialists for multiple sites across the United States• Obtained CLIA certification (moderate and high complexity) for all sites• DEA licensure point of contact• Generated all patient in-take paperwork and procedures• Assisted with supply procurement• Oversaw clinical compliance with all local, state and federal accrediting andregulatory agencies• Worked with cross functional team to build out complete IT infrastructure to support ClinicalOperations (EMR and LIS for onsite testing)

Responsible for creation and amendment of all SOPs• Audit all laboratory staff to ensure proper credentialing and certifications• Coordinate with SAMHSA, CLIA, FDA, DEA and CAP for regulatory compliance of thelaboratory. Assisted with all inspections at all locations and affiliates• Successfully obtained Forensic accreditation through CLIA, CAP and SAMHSA, maintained all current accreditation and certifications and served as the company representative for agency communications and activities• Maintain detailed records of all laboratory incidents and complaints• Manage all laboratory personnel's HR records and credentials• Lead manager for successful FDA 510(k) filing for diagnostic device• Assist with import/export actions related to medical devices• Ensure all personnel and processes at all locations are compliant to local, state, and federal law • Conducted quarterly internal audits • Maintained 100% compliance for all facilities with accrediting and regulatory agencies

Doctor Of Philosophy - Phd, Biomedical Science

Post-Baccalaureate, Biochemistry

Bachelor'S Degree, History