Responsible for product and facility registrations with respective regulatory agencies and for compliance with regulatory requirements for medical devices, cosmetics and OTC pharmaceuticals in US, Canadian and Latin American markets. Responsible for performing gap analysis and enhancing existing QMS to comply with ISO 13485, ISO 9001 and FDA QSR requirements and for planning, developing and implementing EMS and OHSAS in US and Canadian facilities.• Proposed and implemented regulatory strategies during the development of new products that would prevent launch delays and ensure compliance with regulatory requirements.• Submitted and maintained all documents and data required for product and facility registrations and ongoing maintenance updates. Lack of or expiration of registration would have prevented sales of the products in any given market. • Participated in continuing education opportunities to ensure compliance with changing regulatory and ISO standard requirements including those offered by BSI, RAPS and the FDA.• Upon joining the company, identified a number of areas in which the QMS was weak or noncompliant with ISO 13485, ISO 9001 and/or QSR requirements and drafted procedures to strengthen the system. Follow-up internal audit observations were decreased both in number (from 24 to 6) and in severity from major to minor nonconformances. • As part of global corporate initiative, was appointed project leader and local management representative responsible for planning, development and implementation of Environmental Management Systems (EMS) for facilities in the US and Canada. Systems were implemented on schedule and received certification upon initial audit.• Performed objective internal audits of EMS in SSL facilities to ensure ISO 14001 compliance.

Served as senior executive for North American affiliate of a Belgian organization which marketed, sold and distributed radioactive medical devices for cancer therapy. Responsibilities included managing marketing, sales and distribution activities as well as underlying functions necessary for successful operations. Due to small size of the US-based organization, was directly involved in regulatory and quality system compliance and served as Radiation Safety Office for the facility.• Effectively managed through the difficult decision to withdraw a product line by working closely with customers to ensure that their surgical programs continued with a minimal of disruption.• Worked with development team to launch a new innovative, yet cost effective, radiation source. Prepared all regulatory submissions and procedures for this active implantable device achieving market clearance in less than 120 days. • Renegotiated healthcare benefit contract reducing company costs by 27% while providing equivalent services to employees.

• Positioned a small, start-up organization as an innovative, customer service driven company. By demonstrating the benefits of unique features of the products, significant accounts, previously entrenched with large competitors for years, were won.• Developed operational procedures and processes in compliance with GMP, ISO 9001 and later ISO 13485 resulting in successful regulatory (FDA and GA DNR) inspections.• Worked closely with corporate quality team to develop in-house employee training for quality management and for radiation safety. Resulting training programs better addressed unique facility operations while providing substantial reduction in training costs.• Managed a wide scope of responsibilities including marketing, sales and distribution operations, yet remained highly involved and productive in direct sales. Specifically, out of $7.2M annual revenues, was personally responsible for $2.25M in sales.• Hired, trained and managed 7-member US team involved in distribution, customer service, marketing and sales. Extensive cross training allowed efficient and dependable operations which would have otherwise required the hire of 3 additional employees.• Negotiated supply and distribution contracts and managed relationships with major domestic and international marketing partners increasing sales by more than 300% over a 2 year period.