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Holly Hallock is listed as Director of Global Strategic Regulatory Initiatives at Teleflex, a with 51 employees, based in Durham, North Carolina, United States. AeroLeads shows a matched LinkedIn profile for Holly Hallock.
Holly Hallock previously worked as Director of MDR at Teleflex and Director of Regulatory Affairs and Regulatory Operations at Teleflex. Holly Hallock holds Master Of Science - Ms, Regulatory Affairs For Drugs, Biologics, And Medical Devices from Northeastern University.
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Creative, solution-driven leader with 14 years of experience in Regulatory Affairs, Regulatory Operations, Medical Device Regulations (MDR), Global Supply Chain, and Quality Engineering. Cross-functional partner responsible for acquisitions and integrations, generating and executing on strategic goals, investing in an engaged and high-performing culture of over 20 employees.
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A career timeline built from the work history available for this profile.
Wayne, Pa, Us
-Responsible for identifying strategic solutions to executive challenges in order to sustain and grow business globally-Create governance and remediation efforts to address backorder tied to regulatory issues (reduced backorder by >$3M)-Lead cross-functional assessment team to develop end-to-end connectivity for product version control, which increases forecasting accuracy and reduces scrap
Wayne, Pa, Us
-Managed global impact and implementation for MDR compliant product across seven Business Units and eight design centers-Created operational efficiency for global manufacturing and inventory plans tied to regulatory registrations
Wayne, Pa, Us
-Led functional aspects of $170M Standard Bariatrics acquisition and integration, which will contribute to high-growth for the Surgical Business Unit-Maintained >98% forecast accuracy for $2.5M OPEX budget-Developed Regulatory Operations department, which reduced outstanding international requests by 90%-Represented all Business Unit regulatory leadership on Functional Leadership Council, which reported into the President of the Americas-Protected $32M revenue in EMEA by securing MDR certificates ahead of schedule-Provided primary support in front room during FDA inspections
Wayne, Pa, Us
-Significantly improved cross-functional relationships with Marketing, Sales, and R&D by introducing a creative and solution-driven culture-Streamlined functional responsibilities to increase NPD and sustaining output-Integrated international responsibilities into the Surgical Business Unit
Wayne, Pa, Us
-Led functional aspects of $1.1B NeoTract acquisition and integration, which contributed to 111% growth in company stock price-Trained and guided employees in the authoring of, and successful clearance of, 510(k)s critical to the growth of the Surgical Business Unit-Provided primary support in front room and back room during Notified Body audits-Authored clinical evaluations in accordance with MedDev 2.7.1 Rev 4
Wayne, Pa, Us
-Authored numerous successful medical device submissions for major markets-Participated as a core team member in new product development projects promoting organic growth for the business-Assisted in the development of an electrical safety test plan for new products per IEC 60601 edition 3.1, which included the generation of usability specifications and a usability SOP-Acted as regulatory lead in the development and execution of multiple animal studies, including formative and summative usability studies, design validation studies, and GLP studies
Wayne, Pa, Us
-Managed sustaining portfolio for 8 legacy product lines-Supported initiation of GS1 and UDI compliance project
Wayne, Pa, Us
-Managed international registration requests
Wayne, Pa, Us
-Authored regulatory SOPs and work instructions-Prepared and submitted 30+ CFGs
Raleigh, North Carolina, Us
• Produced research data using computer software programs and presented results to both peers and professors.• Headed research groups focused on Brownian motion and acoustics.• Managed laboratories comprised of 24 research students each.• Completed training program to operate PULSTAR nuclear reactor laboratory.
Other employees you can reach at vantage-os.com. View company contacts for 51 employees →
Brett Ylonen
Colleague at TeleflexGreater Minneapolis-St. Paul Area, United States
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DZ
Darin Zafferano
Colleague at TeleflexClovis, California, United States
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Corey Henry
Colleague at TeleflexWest Haven, Connecticut, United States
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Karen Wood
Colleague at TeleflexWinterville, North Carolina, United States
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Arturo Flores
Colleague at TeleflexTijuana, Baja California, Mexico
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Steven Helser, Mba
Colleague at TeleflexGreater Boston, United States
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Rose Prendergast
Colleague at TeleflexIreland
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David Kinsel, Pe
Colleague at TeleflexSylvania, Ohio, United States
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Charles Smith
Colleague at TeleflexChicago, Illinois, United States
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Maria Santorelli
Colleague at TeleflexMalden, Massachusetts, United States
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Quick answers generated from the profile data available on this page.
Holly Hallock works for Teleflex.
Holly Hallock is listed as Director of Global Strategic Regulatory Initiatives at Teleflex.
Holly Hallock is based in Durham, North Carolina, United States while working with Teleflex.
Holly Hallock has worked for Teleflex and North Carolina State University.
Holly Hallock's colleagues at Teleflex include Brett Ylonen, Darin Zafferano, Corey Henry, Karen Wood, and Arturo Flores.
You can use AeroLeads to view verified contact signals for Holly Hallock at Teleflex, including work email, phone, and LinkedIn data when available.
Holly Hallock holds Master Of Science - Ms, Regulatory Affairs For Drugs, Biologics, And Medical Devices from Northeastern University.
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