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In an environment where medical product regulations seem to be expanding continuously, proportional investment in compliance infrastructure and controls runs the risk of diminishing returns. The key to achieving the right balance of commercial success and compliance is to focus on continuous improvement, specifically root-cause analysis.
The US Food and Drug Administration (FDA) has published a new draft guidance intended to assist industry with developing products under the agency's so-called "Animal Rule," a regulatory pathway intended to facilitate approvals of medical countermeasures to rare, emerging or serious pathogens.
Medical Device, Quality Assurance & Quality Control, Quality/Risk Management
4 Year Degree
Responsible for supporting Straumann North America’s Post Market Surveillance and Quality functions in accordance with company, FDA, and Health Canada requirements. Responsible for management of the Complaint Handling team to ensure timely review and closure of complaints. Review and file eMDRs when required. Support the implementation and maintenance of the Quality System for Sales North America.
Major responsibilities of the Position:
Manage Complaint Handling Team to ensure timely review and closure of complaints
Manage eASR and eMDR reporting process to the FDA
Manage medical device reporting, recalls, removals, and corrections
Implement recall activities and work with corporate regulatory and quality, including corporate product safety officer, to asses recall-related events
Develop job descriptions, set/monitor targets and development objectives, and mentor direct reports
Monitor appropriate metrics to track quality/regulatory and process improvement
Support the quality management system in accordance with FDA regulations
Develop and maintain internal operating policies and procedures relating to regulatory and quality activities
Manage CAPA activities
Support FDA and Health Canada inspection activities for Straumann and Instradent
Responsible for maintaining tissue bank licensing and certifications according to federal and state regulations
Prepare and deliver periodic regulatory/quality training seminars to internal groups as needed or required
Deputy Management Representative under ISO Standard and QSR
Must possess strong leadership skills, demonstrating a track-record of success in a high-growth environment
Excellent written and oral presentation skills
Strong analytical skills combined with a solutions-oriented mentality
Experience with US FDA and Health Canada inspections
Experience with both consumable and durable medical technologies preferred
Required Knowledge and Skills:
BS degree (preferably in science/engineering), advanced degree preferred
Minimum of 5 years of experience in a medical technology company with both regulatory and quality experience
Minimum of at least 3 years of management of a regulatory group within a medical technology company
Demonstrated ability to lead functional team and operate within a global, matrix-management environment
Straumann is a leading provider of solutions in implant dentistry and dental tissue regeneration. Our mission is to enable dental professionals to restore their patients’ oral function and esthetics through effective, reliable, and safe treatment methods.
In 2005, we opened our new state-of-the-art national headquarters. It embodies the spirit of Straumann with its 160,000 square feet of open,... clean lined modern space. By combining manufacturing, training and education, marketing, and customer service under one roof, we are now able to offer the highest quality of products and services available in the marketplace to our customers.
Straumann USA, LLC, located in Andover, MA, is the US subsidiary of Straumann Holding, headquartered in Basel, Switzerland. As the largest dental implant company in the world, the Straumann Group of companies has an active presence in more than 50 countries.