Medical Device Regulation & Manufacturing Leader

WILLIAM BANKER

Cincinnati, OH Phone: 513-***-**** Email: ********@*****.***

Dynamic and results-driven executive with a proven track record of founding and scaling companies across diverse industries, including medical devices, chemical manufacturing, and logistics. Expertise in regulatory compliance, product development, and market expansion with a strong ability to navigate complex regulatory landscapes, drive innovation, and lead cross-functional teams to achieve strategic business objectives. Skilled in transforming ideas into market-leading products, merging technical acumen with strategic vision to optimize operations, increase market share, and sustain business growth. Recognized for strong leadership, client relationship management, and driving revenue through innovative sales strategies in the healthcare sector. Dedicated to delivering value in high-stakes environments and consistently achieving impactful results.

Core Competencies

Strategic Leadership Regulatory Compliance Product Development Healthcare Sales Strategy Operations Management Quality Assurance Supply Chain Optimization Cross-functional Team Leadership Business Development Manufacturing Process Improvement Market Expansion Regulatory Documentation & Submission Client Relationship Management Process Optimization

Work Experience

CEO Hair Science Systems - Cincinnati, OH 2011 …… Present

Directed the development and manufacturing of a medical device to preserve hair for chemotherapy patients.

Managed the regulatory approval process, including submissions to the FDA and other international regulatory bodies.

Product testing – ground testing – safety testing human factor testing V and V testing – developing IFU’s

Collaborated with regulatory consultants to ensure compliance with all applicable standards and guidelines.

Established partnerships with leading oncology centers – GPAs – hospital networks to implement clinical trials and gather data

Developed and executed a strategic sales plan to introduce the product into healthcare facilities and clinics.

Led the development of educational materials and training programs for healthcare professionals to support product adoption.

Oversaw the manufacturing process, ensuring quality management – control and adherence to regulatory standards.

Coordinated with marketing teams develop messaging aligned with the product’s regulatory status and benefits.

CEO Absolute Hair Growth - Cincinnati OH 2006…… 2015

Spearheaded developing and manufacturing a laser-based medical device for terminal hair regrowth.

Navigated the regulatory landscape, ensuring the product met all necessary compliance requirements for market entry.

Directed sales and marketing efforts to position the product within the healthcare and wellness sectors.

Engaged with key opinion leaders and healthcare providers to drive product awareness and acceptance.

Coordinated with manufacturing teams to maintain high quality and regulatory compliance standards.

Provided administrative oversight to ensure all regulatory documentation was accurate and up to date.

Led initiatives to expand the product’s reach into international markets, addressing regulatory challenges in each region.

Utilizing low – level lasers (LLL) if therapy with midrange wavelengths to safely stimulate blood flow

Assist in cancer patients affected with [CIA] chemically induced alopecia

CEO Public Warehouse Company - Cincinnati, OH 1992…… 2008

Led the operations of a public warehouse and distribution firm specializing in storing and distributing specialty products for various industries.

Developed strong client relationships, ensuring seamless distribution and compliance with specific industry regulations.

Managed the warehouse’s compliance with industry standards, including temperature control and product handling requirements.

Coordinated with sales teams to align distribution strategies with client needs and regulatory requirements.

Provided administrative leadership in maintaining all regulatory certifications and documentation related to product storage.

Implemented process improvements to enhance operational efficiency and compliance with standards.

Developed and managed logistics strategies to ensure timely and accurate delivery of products.

Engaged in regular audits to ensure the warehouse operations met all relevant regulatory and safety standards.

Developed a comprehensive quality assurance program to maintain high standards in product manufacturing.

Negotiated contracts with suppliers and distributors, ensuring cost-effective and compliant operations.

Founder & General Manager Amity Chemical Company - Cincinnati, OH 1981 1990

Founded and managed a company specializing in manufacturing chemical products.

Directed product development processes focused on compliance with industry standards and regulations.

Managed relationships with regulatory bodies to ensure timely approvals and compliance with all necessary guidelines.

Led sales efforts focusing on the benefits and compliance of the company’s products.

Provided administrative oversight for preparing and submitting regulatory documents to relevant authorities.

Developed four specialized concrete additives for enhanced durability and performance in high-traffic areas.

Engineered high-performance paint formulations designed for long-lasting application on highways and airport runways.

Implemented advanced curing techniques for concrete, ensuring durability and longevity.

General Manager Amity Drum Service - Cincinnati, OH 1979 1990

Managed the reconditioning of metal drums for industries including paint, chemical, and oil packaging.

Ensured operations met stringent industry safety and quality standards for products.

Led a team of employees, driving productivity improvements and maintaining high safety standards.

Developed and implemented a quality control program that reduced defects and ensured compliance with regulations.

Negotiated long-term contracts with key clients, ensuring consistent demand and business stability.

Coordinated logistics to meet clients' specific needs, ensuring timely and safe delivery of products.

Implemented training programs to keep staff updated on the latest industry regulations and standards.

Managed inventory systems to track and ensure the availability of reconditioned drums for clients.

Ensured compliance with ICC 17 E regulations while minimizing costs associated with transporting hazardous materials.

Negotiated bulk shipping contracts, leading to significant reductions in shipping costs for chemical, pink, and oil companies.

Implemented route optimization strategies, cutting transportation expenses for hazardous chemicals and asphalt manufacturing materials.

General Manager Cincinnati Sash and Door - Cincinnati, OH 1975 1979

Oversaw the manufacturing and distribution of window and door units.

Led production and distribution teams, ensuring high-quality output and customer satisfaction.

Introduced steel door units for both commercial and residential

Streamlined production processes, resulting in increased output and waste reduction.

Developed strong relationships with key clients, resulting in repeat business and long-term contracts.

Introduced new product lines based on market demand, increasing revenue and expanding market share.

Provided administrative leadership in managing regulatory submissions and maintaining compliance documentation.

Developed a comprehensive financial strategy to reverse negative six figures to a positive six-figure cash flow within eighteen months.

Education

Marietta College – – Petroleum Engineering

University of Cincinnati – Bachelor of Science

Different Graduate courses

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