RESPONSIBILITIES• Originate and maintain certifications (CE, UL, CSA, Intertek) for all product lines (medical and commercial).• Supervise in-house test laboratory (level 2 with UL and Intertek).• Regulatory representative for compliance audits (ISO9001/13485, customer, certification houses)ACCOMPLISHMENTS• Developed triage system to clear ECO changes and vet against standards. Reduced workload 1 man-year/year.• Hosted numerous audits and visits with no significant findings issued.• Certified three (3) new product lines (1-UL, 2-Intertek).

RESPONSIBILITIESRA and product compliance authority for five (5) technologies and service distributed world-wide.Radiation and Laser Safety Officer for all sites (X-Ray, Rad Materials, Class 4, 3b lasers).EH&S lead for corporate level ISO-14001 and OHSAS 18001 programs (integrated with ISO-9001) – 7 sites (multiple countries).ACCOMPLISHMENTSCreated initial corporate regulatory function to deal with requirements due to acquisitions (XRF, XRD, Ultrasonic, laser, Class 1 Microscope) and ever increasing compliance issues throughout the world. Structured and executed successful and sustainable RoHS compliance program for all products.Oversaw acquisition transfers of three (3) business for RA, QA and EH&S (one brought me to Olympus). Developed schemes for training, wrote and taught multiple courses. Instituted standardized EH&S and compliance training program. Lead teams through multiple projects for compliance recertification (CE, KCC, GHS, CLP, REACH, BT/WiFi, ATEX, CCC, PSE)Implemented new strategy to increase recycling resulting in 5T per month recycled in first year (10% increase in year 2). Drove reportable Injury Rate down 5 consecutive years to below 0.5 through awareness and technique training.

Write and mitigate submissions to ensure compliance with various regulating agencies (FDA, Canada, State of MA, EU).Author and conduct radiation and safety training and monitor hazardous waste disposal program.Design strategies for current and future products complance with US (FDA), Canada, EU (CE, CB), and other (DNV, GOST, RoHS) regulations. Determine compliance with import/export regulations. Develop QA program, including control and standardization of incoming and outgoing QC, CAPA system and document control.

Manufacturer of radiation-based equipment for non-destructive testing, oil well logging and medical treatments.Senior staff technical lead for research, design and manufacturing engineering function..Develop and present proposals for new projects (international and US)Extensive technical and administrative interaction with regulatory agencies - US & international.Committee member of standards organizations (ASTM, ANSI) for new product and packaging standard.