NXStage Medical Inc. Director, Post Market Surveillance in Lawrence, Massachusetts
Director, Post Market Surveillance
The incumbent will provide support and direction to the execution of the complaint processes throughout the organization to monitor and analyze product performance data from a variety of internal and external sources.
• Oversee Complaints processing in compliance with FDA Quality System Regulation, 21 CFR Part 820. Manage the timely in-flow of Customer Events, the assignment of investigation responsibilities, and expedient processing and closure. Facilitate the performance
of other functions’ roles as they impact effective complaint handling, specifically related to direct patient interactions and the processing of returned products.
• Manage personnel and all associated activities of the Complaints Processing group.
• Oversee Postmarket Vigilance activities. Acts as MDR/Vigilance/ADR pre submission reviewer.
• Facilitate Health Hazard Evaluations/Health Hazard Analysis to support timely identification of potential field actions
• Identify process improvement opportunities to enhance surveillance and to increase efficiency of complaints processing group. Document rationale for process and any subsequent changes using appropriate SOP’s.
• Define reports to identify delinquency or backlog in all aspects of Postmarket Surveillance, including Customer Event processing, product returns, investigations, and engineering feedback. Address such delinquency with responsible functional managers.
• Facilitate requests for additional information from global regulatory authorities.
• Manage preparation and reporting of Quality Data for purposes of field surveillance and the company’s Management Review process.
• Based on surveillance findings, collaborate with technical groups to identify product improvement opportunities; assist in establishing engineering priorities.
• Support the development, management, and meeting of departmental budgets.
Education & Qualifications:
• B.S. in a clinical or engineering or related field preferred
• 10+ years experience in Quality Assurance, Regulatory Affairs, or Post-market Surveillance in the medical device industry.
• 5+ years management experience
• Experience in process and product development of medical devices is preferred.
• Working knowledge of FDA Medical Device Regulations including Quality System Regulation 21 CFR Part 820,and applicable international quality standards including ISO 13485:2003, Canadian MDR, Medical Device Directive, and drug regulations as they relate to
• Strong analytical, interpersonal, and management skills.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities.
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- The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access
to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure
is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41