Regulatory Affairs & Quality Leadership Executive

Page * of * Ralph Buster Jr 330-***-**** *.********@******.***

Ralph Buster Jr.

Canton, Ohio 330-***-**** *.********@******.*** LinkedIn PROFESSIONAL SUMMARY

Regulatory Affairs and Quality Assurance Executive Compliance & Engineering Management Expert Results-driven executive with 30+ years of leadership in Regulatory Affairs, Quality Assurance, Compliance, and Engineering Management within the medical device and life sciences industry. Proven track record in developing and executing FDA and globally compliant Quality Management Systems (QMS), supporting business operations and product development across Class I–III devices. Recognized for aligning RA/QA strategies with corporate goals, proactively resolving compliance issues, and leading global regulatory initiatives. Technically proficient in polymers and metals, with hands-on expertise in formulation, design, and manufacturing. Adept at driving KPIs, cost-saving initiatives, and continuous improvement across multi-site operations. PROFESSIONAL HIGHLIGHTS

● Successfully led regulatory integration and quality remediation for six acquired facilities.

● Implemented global quality systems aligned with FDA, ISO, MDSAP, EU MDR, and other international regulations.

● Delivered $2M in annual cost savings through process optimization and quality initiatives at Pioneer National Latex. Global Regulatory Compliance Regulatory Due Diligence Compliance Remediation QMS Integration & Oversight Process Validation Supplier Quality Management Regulatory Strategy and Execution Risk Management & HHE KPI & Performance Optimization Design Controls Cross-Functional Leadership Change & Document Control International Regulatory Engagement Field Actions & Recalls Audit Management PROFESSIONAL EXPERIENCE

Zimmer Biomet (Surgical Division), Dover, Ohio March 2013 - January 2024 Sr Director, Regulatory Affairs & Quality Assurance Led regulatory and quality oversight across four Class I & II medical device manufacturing sites.

• Directed global regulatory affairs, including FDA, ISO, UL audits, product/facility registrations, technical files, and labeling compliance.

• Managed NPI regulatory submissions, recalls, field actions, and controlled quality records, and holds.

• Oversaw QMS operations, including document control, management review, metrics reporting, and systems integration.

• Led risk management activities, including risk files, microbiology lab oversight, and Health Hazard Evaluations (HHE).

• Supervised QA functions: engineering, inspection, calibration, validation, and project management across four sites.

• Managed supplier quality processes, including approvals, product transfers, and documentation.

• Key contributor in due diligence and integration for six acquired sites, including QMS harmonization. The Hygenic Corporation/Performance Health, Akron, Ohio October 2001 - March 2013 Vice President, Corporate Compliance

Provided enterprise-wide leadership for Quality, Regulatory, Environmental Health & Safety, Legal, and IP across three manufacturing sites (U.S. and Malaysia), supporting OTCs, cosmetics, and Class I – III medical devices (OEM and proprietary brands).

• Oversaw global facility/product registrations across 65+ countries for OTCs, cosmetics, and Class I–III medical devices.

• Engaged directly with FDA, OSHA, EPA, and U.S. Customs on compliance matters.

• Led consolidation of multiple operations into a single facility; implemented 21 CFR Part 11-compliant document control.

• Directed equipment design for casting, braiding, molding, and extrusion. Page 1 of 2 Ralph Buster Jr 330-***-**** *.********@******.*** Pioneer National Latex, Ashland, Ohio February 2000 - October 2001 Technical & Quality Director

Directed R&D, technical services, and quality operations across two facilities producing latex and plastic products.

• Restructured departments, implemented ISO certification, and realized $2M in annual cost savings.

• Led equipment and mold design for blow molding, roto-cast, compression, and injection processes. C.R. Bard, Inc (Urological Division), Moncks Corner, SC July 1996- February 2000 Production & Process Control Manager

Managed production and process control for a 450-employee Class II medical device facility manufacturing urinary catheters.

• Reduced scrap by 5% through restructuring and continuous improvement.

• Led the design and launch of two new product lines from concept to full-scale manufacturing. Additional Experience available upon request

EDUCATION

Bachelor of Science - Chemistry/Biology, Liberty University, Lynchburg, VA TECHNOLOGY SKILLS

Microsoft Office Suite Trackwise Windchill ETQ PROFESSIONAL MEMBERSHIPS & CERTIFICATIONS

AAMI (Association for the Advancement of Medical Instrumentation) ● RAPS (Regulatory Affairs Professionals Society) ● ASQ

(American Society for Quality) ● ACS (American Chemical Society) ● Lean Six Sigma Green Belt

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