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Jackie Ferro is listed as Global Regulatory Affairs and Quality Assurance Executive | Medical Devices | Pharmaceuticals | In Vitro Diagnostics | Consumer Products | Digital Health at Integra LifeSciences, based in New York City Metropolitan Area, United States. AeroLeads shows a work email signal at drivemedical.com, phone signal with area code 516, 610, and a matched LinkedIn profile for Jackie Ferro.
Jackie Ferro previously worked as VP of Regulatory Affairs, Codman Surgical Specialty at Integra Lifesciences and Advisory Council Member at Glg. Jackie Ferro holds Bs, Chemical Engineering from New Jersey Institute Of Technology.
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AeroLeads found 1 current-domain work email signal for Jackie Ferro. Compare company email patterns before reaching out.
Global Regulatory Affairs and Quality Assurance Executive Leader | Medical Devices | Pharmaceuticals | Consumer Products | Digital HealthA highly accomplished, transformational global executive and change agent within the regulatory affairs and quality assurance space in the medical device, in vitro diagnostics, pharmaceutical, consumer product and digital health industries. Exceptionally strong strategic business partner with consistent contributions to top line sales.Impressive contributions include inspiring and building out QA/RA/CA for a consumer products company creating a digital health, MedTech portfolio, developing and executing the regulatory strategy for a new OEM/CM sterile medical device company, creating new revenue streams by building new quality systems in pharmaceuticals and human cell and tissue products enabling licensure and sale of those products, compliance remediation of consent decrees and warning letters, successful clearance and approvals of regulatory submissions domestically and internationally.Areas of Expertise:21 CFR Part 820 (FDA Medical Device QSR) * 21 CFR Parts 210 and 211 (FDA Pharmaceutical cGMPs) * 21 CFR Parts 1270 and 1271 (FDA Human Cell and Tissue Practices HCTPs) * FDA Warning Letter Remediation * Clinical Quality Assurance * ISO 13485 * 21 CFR Part 58 (Good Laboratory Practices (GLP)) * ISO 14971 * Certified Lead Quality Auditor * Regulatory Submissions * 510k * DeNovo * PMA * CE Marking
Listed skills include Validation, Quality Assurance, Fda, Change Control, and 38 others.
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A career timeline built from the work history available for this profile.
Princeton, New Jersey, Us
Global regulatory affairs executive leadership for Codman Specialty Surgical which is a global leader in neurosurgery medical devices and surgical instrumentation.
New York, Ny, Us
Expert council in regulations, quality assurance and manufacturing for medical devices, pharmaceutical and consumer products. Experienced in developing, improving and transforming organizations within start-ups through full scale global operations.
London, United Kingdom, Gb
Expert council in regulations, quality assurance and manufacturing for medical devices, pharmaceutical and consumer products. Experienced in developing, improving and transforming organizations within start-ups through full scale global operations.
Palo Alto, California, Us
Executive leadership and global head of regulatory, quality and clinical affairs focused on building out the compliance foundation for a new start-up under Kohler Company.
Oakland, New Jersey, Us
Global Vice President over Topcon Medical Systems and Topcon Healthcare Solutions focused on ophthalmic medical devices and software solutions for telemedicine. Responsible for the Quality Management Systems, Quality Assurance, Regulatory Compliance and Regulatory Affairs functions. Serving as US Agent for all of Topcon's Eyecare Businesses.
New York, New York, Us
Global strategic and technical lead responsible for remediation support of Pfizer's on-market medical device and combination products design history file lifecycle management and related investigation activities for external supply and contract manufacturing organizations.
Jupiter, Fl, Us
Executive leadership over Quality Assurance and Regulatory Affairs for Captiva Spine which is a class II medical device company specializing in spine with a new portfolio in biologics. Directly accountable for corporate compliance to 21 CFR Parts 820 and 1271, satisfaction for all domestic and international regulatory licensing and development of 510(k) premarket applications. Achieved clearance for four products during my tenure including one HCT/P and three class II medical devices. Hosted FDA, CBER Division, in May 2019 for their first biologics inspection which resulted in zero 483 observations.
Port Washington, Ny, Us
Executive leadership over Quality, Regulatory and Compliance for a medical device company specializing in durable medical equipment with over 5000 products ranging from consumer products through class II medical devices. C level governance over approximately 35 sites including corporate, manufacturing and distribution facilities. Led FDA warning letter remediation for a class II respiratory subsidiary and developed quality systems for acquisitions requiring remediaton and/or upgrade in order to sell products globally. Built out the compliance infrastructure and mitigated risks to improve product quality and safety as well as attract investors which led to the successful sale of Medical Depot in 2017.
Telford, Pa, Us
Quality and Regulatory executive leadership for Secant Medical which specializes in implantable biomaterials and medical fabric engineering technologies essential to biomedical textile medical devices. Inspired, designed and executed a regulatory strategy which led to the realization of SanaVita Medical which is a sister company focused on manufacturing sterile finished devices thus bolstering overall revenues for what is now the Secant Group.
Bethlehem, Pa, Us
Quality Head for the Allentown, Bethlehem and Breinigsville PA campuses of B. Braun Medical for the design, development, manufacturing, sterilization, and distribution of medical devices used for drug delivery, IV therapy, pain control, dialysis and vascular intervention in hospitals, outpatient surgery centers and home care.
Kalamazoo, Mi, Us
Management Representative and highest ranking quality leader from 2010 through 2011 defending the quality system to regulators such as FDA, Notified Bodies, TGA and others. Site quality leader for the quality systems integration of Orthovita Inc. after acquisition by Stryker in June 2011.
Bethlehem, Pennsylvania, Us
Directed corporate and plant wide quality systems activities for a small medical device company manufacturing PMA and 510K devices. Hosted regulatory inspections for FDA, Notified Bodies, Canada and rest of world. Provided compliance oversight for 510K and PMA devices for OraSure.
London, England, Gb
Led the remediation of FDA regulatory observations for Chanel US Operations in 2004. Successfully built the infrastructure of a pharmaceutically based quality system by 2005 which resulted in zero observation inspections from 2005 onward for Chanel US Operations. Designed and implemented the use of SAP for managing all aspects of quality control and assurance which became adopted globally within the company.
New York, New York, Us
Led all validation activities associated with manufacturing consumer products and for Pfizer Inc. including but not limited to cleaning, process, equipment and software validation.
Miami Lakes, Fl, Us
Process engineer for the first coated coronary stents born out of Johnson & Johnson Interventional Devices which predates their Cordis acquisition. Responsible for performing technical transfer/validation for J&J Consumer and OCD. Completed my time with J&J working in supplier quality for external manufacturers of minimally invasive cardiovascular and wound care devices.
Switzerland 🇨🇠, Ch
Began my career with Roche supporting the manufacture of Vitamin C with their previous Vitamins and Fine Chemicals division. Later moved into project engineering support to the PCR Diagnostics business at Roche Molecular Systems. Assessed manual packaging operations and specified equipment and automation to improve Operations efficiencies.
Quick answers generated from the profile data available on this page.
Jackie Ferro works for Integra LifeSciences.
Jackie Ferro is listed as Global Regulatory Affairs and Quality Assurance Executive | Medical Devices | Pharmaceuticals | In Vitro Diagnostics | Consumer Products | Digital Health at Integra LifeSciences.
AeroLeads has found 1 work email signal at @drivemedical.com for Jackie Ferro at Integra LifeSciences.
AeroLeads has found 4 phone signal(s) with area code 516, 610 for Jackie Ferro at Integra LifeSciences.
Jackie Ferro is based in New York City Metropolitan Area, United States while working with Integra LifeSciences.
Jackie Ferro has worked for Integra Lifesciences, Glg, Alphasights, Kohler Ventures, and Topcon Healthcare.
You can use AeroLeads to view verified contact signals for Jackie Ferro at Integra LifeSciences, including work email, phone, and LinkedIn data when available.
Jackie Ferro holds Bs, Chemical Engineering from New Jersey Institute Of Technology.
Jackie Ferro is listed with skills including Validation, Quality Assurance, Fda, Change Control, Quality Auditing, Capa, Gmp, and Quality Management.
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