Health Care

applicants

Tradition runs deep in South Bend. After all, Notre Dame and its century of storied football are at the heart of the community. But the community of South Bend reaches far beyond the sidelines.  South Bend is brimming with rich history, world-class arts and entertainment, and wonderfully diverse neighborhoods.  It seems each season is met with anticipation. Summers are greeted with eagerness as outdoor activities take center stage. Autumn is brought in with great pageantry as the Fighting Irish™ take to the field and students return to campus. Winter arrives with mittens, hot chocolate and the first snowman of the year. And then spring is welcomed with new growth and new team lineups.Looking for a change of scenery?  Our client is a high tech dental manufacturing company that provides dentists, labs, and patients within North America with the ultimate in esthetic dental solutions.  Their solutions empower dental professionals to provide patients with the most natural looking restorations while respecting a healthy and conservative approach to clinical dentistry.   For this leading global player with a 150 year success story, we seek a  Director, Quality Assurance and Regulatory Affairs.   In this role you will  direct the overall QA activities for the manufacturing of dental and medical devices in an FDA/ISO 13485/Canada regulatory environment.   You will direct and oversee the development and registration of new products produced in South Bend and Europe that will be sold in the US or Canada.  You will oversee Canada registrations, FDA registrations, ISO registrations/validations.  You will manage the Quality System and software application (ie HQMS) for the division.  You will coordinate the Quality and Regulatory activities between the division and Germany (parent company).  You will create and submit documents to the regulatory bodies for new products, audit follow-up, general updates, etc.  You will identify and manage product complaints and disposition (ie corrective actions, recalls, etc.).Candidates must have a B.S. degree in science/chemistry.  Preference will be given to candidates with an MBA.  Candidates must have at least seven (7) years experience in the Regulatory/Quality Assurance management areas, preferably with a medical device or pharmaceutical manufacturer.  Must have strong leadership, organizational, communication, problem solving, computer skills, attention to detail, and the ability to multi-task in a fast paced environment.  Must have a customer-centric behavior style to support all customers effectively both internally and externally.Generous salary, excellent team work environment, superior national health & dental insurance, 401k match contributions, paid disability and life insurance, tuition/health club reimbursement, above average vacations / holidays, and much, much more.  This is a great opportunity to join a global leader that is benefiting greatly from substantial growth in the dental industry.  For more informant call 941.739.1400 or submit your resume now by clicking on the web URL below.