Regulatory Affairs Manager

Olympus is a precision technology leader, designing and delivering innovative solutions in healthcare and consumer electronics worldwide.

At Olympus, our ideas have proliferated as rapidly as thetechnology has evolved. We have channeled them both into the groundbreakingproducts that our changing world requires—products like acoustic microscopes,ultrasonic endoscopes, reagent AIDS detection, and digital voice recorders. Or,like the Infinity Stylus, one of the best-selling cameras in history.San Jose, CA - This position is responsible for establishing and maintaining compliance with Food & Drug Administration (FDA) laws and regulations throughout Olympus Medical Equipment Services including the management of complaint processing, various inspections and audits, QSR/ISO compliance, training, CAPA, QIS claims and other department responsibilities. Establish, implement, monitor and maintain the complaint processing system ensuring the effective and timely resolution of all complaint investigations. Follow up with M-BC or the vendor on all required failure investigations to ensure that any identified quality issues are addressed by the manufacturer. Evaluate, investigate, and document all alleged Medical Device Reports (MDRs). Prepare and submit all MDR's, and associated documentation, to the FDA and M-BCs. Interact with the FDA on all MDR matters. Perform quality system audits to insure QSR compliance is maintained together with the coordination of QSR training relating to service and repair activities. Responsible for trend analysis and monthly quality reporting of emerging quality/regulatory issues including but not limited to capturing and analyzing quality cost data, customer satisfaction data and other repair/service related activities to division as well as corporate management representative. Perform other duties as assigned.We believe that our employees are our most important resource and therefore arecommitted to providing a high-quality, competitive rewards package that willhelp you meet your personal needs and goals.

Our Total Rewards package consists of the following items:
Medical
Dental
Pension
401(k) Savings
Flexible Time Off (FTO) program.
Olympus also offers a number ofother benefits and incentives, including:Competitive TotalCompensation, Flexible Spending Accounts (FSA's), Paid Holidays, Flexible WorkHours, Educational Assistance Program, Employee Assistance Program (EAP), VisionBenefits, Temporary Disability, Extended Illness, Long-Term Disability, BasicLife and Accidental Death and Dismemberment (AD&D) Insurance, Supplementaland Family Life Insurance, Travel Accident Insurance, Bereavement Plan, EmployeeDiscount Program, College Savings Plan, Employee Referral Program, Fitness ClubDiscounts.
REQUIREMENTS
(ONLY QUALIFIED CANDIDATES WILL BE CONSIDERED) A minimum of 7 years experience in a drug/device manufacturer /distributor, including a minimum of 2 years supervisory experience, along with a strong concentration in QSR compliance and quality assurance is required. Strong analytical, organizational and communication skills are required. A Bachelor of Science, engineering or scientific discipline, or the equivalent knowledge is required.