Director of Regulatory Compliance @ Johnson & Johnson
Associate Director, Research and Development @ Mentor Worldwide, LLC. a Johnson and Johnson Company
Manager, Research and Development @ Mentor Worldwide, LLC. a Johnson and Johnson Company
Bachelor of Science, Psychology @
Indiana University Bloomington
Research and Product Development leader with a proven track record directing world-class, multidisciplinary engineering teams delivering innovative high-risk medical products to global markets. Strong strategic management skills. Adept at optimizing multi-site resources by setting effective direction and metrics to improve project execution and promote solutions in complex environments, while ensuring financial objectives are consistently met. Skilled technical
Research and Product Development leader with a proven track record directing world-class, multidisciplinary engineering teams delivering innovative high-risk medical products to global markets. Strong strategic management skills. Adept at optimizing multi-site resources by setting effective direction and metrics to improve project execution and promote solutions in complex environments, while ensuring financial objectives are consistently met. Skilled technical presenter with a track record of converting accounts through customer-facing at large conference, educational training, and direct to customer sales visits. Expertise includes:
• Hands on experience with industry innovative research strategies, product development to meet customer needs, and effective requirements management
• Expert level knowledge of global device and drug regulations
• Doctorate in Biomedical Engineering with a concentrating in Neurobiology
• Talent Development & Utilization across multiple geographic locations
• Translated corporate direction into product portfolio, pipeline cadence, program management
• Scientific liaisons for Doctors, Grant Review, and domestic and international government agencies
Director of Regulatory Compliance @ From February 2014 to Present (1 year 11 months) Associate Director, Research and Development @ Reporting to the VP of R&D, directed Mentor R&D global business with professionals in Irving, Texas; Leiden, Netherlands and Mauritius and with a budget of $5M concentrating on strategic streams of new innovation and product development to meet consumer needs and insights, new technologies, and business opportunity. Translated Business Plan to R&D goals and coordinated shared goals with Marketing, Operations and Shared Services. Partnered with legal groups to protect and develop patent strategies.
• Directed cross-functional engineering teams, authored submissions to globally launch 3 FDA Class III and 3 FDA Class II implantable devices by the committed launch date, on budget, one launched 3 months early
• Developed innovation strategy based on company goals, multi-phase development plan for synthetic and drug solution to foreign body reactions, viral based cellulose injectable, and collagen/synthetic construct
• Presented science-based product evidence to customers at multiple large conferences, education-training events, and in doctor office sales calls
• Centralized two European R&D facilities into existing infrastructure to optimize the newly integrated business unit,
• Restructured R&D quality systems, improving efficiency for cross-site engineering teams to leverage shared resources and effectively communicate, ensuring on time product market launch
• Applied Lean Manufacturing principles to reduce waste through Design for Manufacturability and poke-yoke process
• R&D lead for the rapid transfer integration of operations facility into a global supply chains, achieving a lean manufacturing “Pull System” certification for the site, and a culture of Six Sigma 5S+Safety
• Planned and executed R&D coverage for a 300% increase in regulatory audit rate and responses for additional device safety data after market removal of competitor device
• Co-Leader for Women in R&D Leadership Council within J&J Medical Device and Diagnostics group From January 2010 to Present (6 years) Dallas/Fort Worth AreaManager, Research and Development @ Manage Research and Product Development for Class II and III medical devices, biologics, and combination devices. From July 2008 to January 2010 (1 year 7 months) Dallas/Fort Worth AreaSenior Engineer, Research and Development @ Achieving market clearance in US and OUS during the first two years of tenor for CPX3 (Medical Device), and R&D review for Neoform (Biologic) and Puragen (Class III combination product). Authored critical documents for third and fourth FDA PMA Module for MemoryShape Breast Implant. From March 2007 to April 2008 (1 year 2 months) Dallas/Fort Worth AreaFood and Drug Administration, Office of Regulatory Affairs, Dallas District Office, Consumer Safety @ Inspected over 100 FDA regulated companies including manufacturers of medical devices, pharmaceuticals, APIs, and combination products; clinical investigators; and Internal Review Boards. Conducted fifteen (15) PMA and five (5) PAI inspections. Examples of products audited include: Needle and Sutures, silicone implants, implanted neural stimulators, intraocular lenses, blood pumps, IVDs, sterile parental, solid and liquid dosage forms, modified release dosage forms, and drug delivery patches.
• Applied quality regulations with technical expertise in cGMPs, QSR, QSIT, GLP, GCP, GAMP, and international standards.
• Experienced auditing design and validations for Automated Systems, Injection and Extrusion Molding, Sterile fill and Packaging, Cleaning and Equipment, and laboratory quality systems. GLP and GCP experience in toxicology and all phases of clinical trials.
• Reviewed EO, Gamma, Dry Heat, E-beam, and Steam Sterilization validations. From December 2001 to March 2007 (5 years 4 months)
Ph.D., Neuroscience @ The University of Texas Health Science Center at Houston From 1991 to 1998 Bachelor of Science, Psychology @ Indiana University Bloomington From 1985 to 1990 Philip Michael Steele, Ph.D. is skilled in: FDA, Medical Devices, GMP, Quality System, V&V, R&D, Design Control, Pharmaceutical Industry, Regulatory Affairs, Cross-functional Team Leadership, Clinical Trials, GLP, Six Sigma, Product Development, Manufacturing
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