Posted on Thursday, June 05, 2008
Manager, Medical Devices

A global provider with long history in the imaging business, developing, manufacturing, and marketing products for hospitals, freestanding imaging centers and nuclear pharmacies is seeking a superstar candidate to manage the day to day processes and analysts responsible for handling complaints of medical devices.

Ensuring compliance with FDA regulations, FDA guidances and corporate procedures for complaint handling, MDR reporting and the providing of medical information by Product Monitoring (CPM). Develop, maintain and continually improve formats for organizing and publishing feedback from the field in ways which are relevant and useful to internal customers and corporate and site quality departments. Establish and maintain positive and mutually rewarding relationships with external and internal customers.

Essential Functions

• Responsible for the day to day functioning of PM relative to medical device product complaint handling and the providing of medical information for medical devices.
• Ensure compliance of PM with corporate level procedures for collecting, analyzing, trending, and reporting of post-market feedback reports globally.
• Interface with Tech Service, Field Service (globally), Manufacturing, R&D, OUS QA/RA personnel to assure requirements are covered during investigation of complaints.
• Participate in internal and external audits relative to Product Monitoring and Medical Information.
• Direct the collection of all data necessary to provide monthly product field performance reports to Director Product Monitoring, corporate headquarters and other internal customers.
• Determine workloads and create opportunities to improve efficiency and accuracy of complaint processing.
• Provide approval and oversight for handling of phone and other contact from internal and external customers.
• Develop and perform internal audits of complaint records and their supporting documentation to examine and assess compliance with applicable regulations, guidances and internal operating procedures. Present audit finding metrics in a meaningful way to Director, Product Monitoring. If necessary, make suggestions for corrective actions to processes and procedures when deficiencies in performance of PM personnel or adherence to operating procedures are noted. Archive audit findings and retrieve and disseminate findings when requested to do so.
• Develop and perform internal audits of medical inquiry records of medical devices for compliance with applicable regulations, guidances and internal operating procedures. 10.
• Present audit finding metrics in a meaningful way to Director, Product Monitoring. If necessary, makes suggestions for corrective actions to processes and procedures when deficiencies in performance of specialists or adherence to operating procedures are noted. Archive audit findings and retrieve and disseminate findings when requested to do so.
• Identify, hire, train, develop and manage medical device product surveillance specialists.
• Conduct training on Product Monitoring standard operating procedures for complaint handling and medical information functions for PM Staff as needed.
• Conduct Post Marketing Surveillance training for company personnel out side of PM as called upon to do so.
• Provide product performance expertise on cross-functional project teams as necessary.
• Participate in teams concerned with development or support of products as necessary.

Qualifications

• Education: Bachelor's degree in clinical field or other college degree with relevant experience.
• Experience: A minimum of 5 years in the medical device industry preferably in a quality or regulatory role.
• Thorough knowledge of FDA complaint & MDR reporting regulations required.
• Knowledge of international regulations for complaint and vigilance reporting strongly preferred.

Preferred Skills

• Previous managerial experience
• Experience in the evaluation of medical literature and other scientific reports -Excellent verbal and written communication skills.
• Experience in computer applications such as Microsoft Word, Excel, Access and Power Point.

Compensation and Benefits:

Very competitive plus comprehensive benefits package.

Contact

David Ruyle
888-282-5520
davidr@k2search.com