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MANAGER, POST MARKET SURVEILLANCE-3214131127
Description
Acclarent, Inc., a member of the J&J Family of Companies is actively recruiting for a Manager of Post Market Surveillance, to be located in Menlo Park, CA.
Acclarent, Inc. is a medical device company in Menlo Park, CA that was established in June of 2004. The company is dedicated to the development of innovative devices providing new technologies to further meet the needs of ENT patients. Acclarent's initial focus is on achieving the goals of sinus surgery with novel, endoscopic, catheter-based tools - Balloon Sinuplasty™ devices. Through the Balloon Sinuplasty™ technology and our Relieva® product portfolio we offer ENT patients another option to conventional endoscopic surgical technologies. FDA clearances for these devices were completed in 2005 and the products were commercially launched in the US that same year. Through our core technologies and commitment to innovation, Acclarent will continue to advance novel devices in all areas of ENT. The Senior Clinical Research Associate (CRA) will support pre- and post-market otology clinical studies worldwide.
The Manager - Post Market Surveillance is accountable to develop and maintain a global product safety surveillance process for Acclarent throughout the product lifecycle, with focus on maintaining constant vigilance for patient safety. Responsible to assure benefit/risk ratio of products are continually assessed and addressed when needed. This position is also accountable for all complaints handling, trending & adverse event reporting, including MDRs and MDVs. This position reports to Sr. Director – Quality, and its direct reports include the Acclarent Complaints Handling Unit.
The responsibilities for this role include:
Lead the group to ensure robust investigation for all customer complaints and assure compliance with all J&J Corporate directives including Complaint Vigilance. Manage Product Complaint Process, driving reduction of regulatory exposure through reduction in late MDR/MDV submissions and through increased efficacy in management of product complaints by improvement in multiple complaint process metrics. Provide periodic reports/presentations of product safety issues and provide metrics to support various scorecards/dashboards. Communicate product quality trends and investigation of product quality issues to all appropriate functions and management levels with recommendation for effective resolution. Provide leadership and guidance for effective and timely communication and appropriate escalation of product quality issues to all levels of the organization.
Provide guidance and support for all companywide recalls.
Develop and deliver global quality strategy for complaint handling system.
Individual will be responsible for performing product complaint activities from initial receipt to final report approval per established QSR and ISO standards.
Communicate with R&D, marketing/sales staff, hospital staff, shipping, operations, etc. to ensure all possible information including product returns are completed.
Responsible for supervising and coordinating Failure Analysis activities, including but not limited to performing root cause analysis, problem identification, report generation and approval.Responsible for maintaining complaint database including data entry, analysis and presentation of metrics.
Communicate effectively with all levels of management and functions.
Develop proactive and collaborative working relationships across key disciplines, including R&D, Clinical / Medical affairs and Operations. Will lead and participate in quality system improvement initiatives such as Complaint Handling, NCRs, Deviations, Internal Audits, CAPAs, etc. Responsible for implementing changes to quality system documents such as SOPs, WRK and FMEAs. Will be responsible to support regulatory audits of quality systems.
Qualifications
A minimum of a Bachelor's degree in a Life Science, Engineering, or Physical Science or related discipline required. An advanced degree is preferred. A minimum 4 years Medical Device or similar regulated industry experience is required. A minimum of 2 years supervisory experience is required. Working knowledge of and competence in application of FDA (21 CFR Part 820, 803, 804), Health Canada regulations and Medical Device Directive governing complaints and Medical Device Reporting.
Specific understanding of FDA MDR reporting of Medical Device Vigilance reporting is required. Strong communication skills (written and verbal) are required. Strong collaboration, partnership and teamwork across local and global organizations highly desired. Demonstrated proficiency in problem solving skill sets is required. Ability to influence without authority is required
This position is located in Menlo Park and requires negligible travel.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LINA
Primary Location:North America-United States-California-Menlo Park
Organization: Acclarent, Inc. (6206)
Job: Quality (Generalist)
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
MANAGER, POST MARKET SURVEILLANCE-3214131127
Description
Acclarent, Inc., a member of the J&J Family of Companies is actively recruiting for a Manager of Post Market Surveillance, to be located in Menlo Park, CA.
Acclarent, Inc. is a medical device company in Menlo Park, CA that was established in June of 2004. The company is dedicated to the development of innovative devices providing new technologies to further meet the needs of ENT patients. Acclarent's initial focus is on achieving the goals of sinus surgery with novel, endoscopic, catheter-based tools - Balloon Sinuplasty™ devices. Through the Balloon Sinuplasty™ technology and our Relieva® product portfolio we offer ENT patients another option to conventional endoscopic surgical technologies. FDA clearances for these devices were completed in 2005 and the products were commercially launched in the US that same year. Through our core technologies and commitment to innovation, Acclarent will continue to advance novel devices in all areas of ENT. The Senior Clinical Research Associate (CRA) will support pre- and post-market otology clinical studies worldwide.
The Manager - Post Market Surveillance is accountable to develop and maintain a global product safety surveillance process for Acclarent throughout the product lifecycle, with focus on maintaining constant vigilance for patient safety. Responsible to assure benefit/risk ratio of products are continually assessed and addressed when needed. This position is also accountable for all complaints handling, trending & adverse event reporting, including MDRs and MDVs. This position reports to Sr. Director – Quality, and its direct reports include the Acclarent Complaints Handling Unit.
The responsibilities for this role include:
Lead the group to ensure robust investigation for all customer complaints and assure compliance with all J&J Corporate directives including Complaint Vigilance. Manage Product Complaint Process, driving reduction of regulatory exposure through reduction in late MDR/MDV submissions and through increased efficacy in management of product complaints by improvement in multiple complaint process metrics. Provide periodic reports/presentations of product safety issues and provide metrics to support various scorecards/dashboards. Communicate product quality trends and investigation of product quality issues to all appropriate functions and management levels with recommendation for effective resolution. Provide leadership and guidance for effective and timely communication and appropriate escalation of product quality issues to all levels of the organization.
Provide guidance and support for all companywide recalls.
Develop and deliver global quality strategy for complaint handling system.
Individual will be responsible for performing product complaint activities from initial receipt to final report approval per established QSR and ISO standards.
Communicate with R&D, marketing/sales staff, hospital staff, shipping, operations, etc. to ensure all possible information including product returns are completed.
Responsible for supervising and coordinating Failure Analysis activities, including but not limited to performing root cause analysis, problem identification, report generation and approval.Responsible for maintaining complaint database including data entry, analysis and presentation of metrics.
Communicate effectively with all levels of management and functions.
Develop proactive and collaborative working relationships across key disciplines, including R&D, Clinical / Medical affairs and Operations. Will lead and participate in quality system improvement initiatives such as Complaint Handling, NCRs, Deviations, Internal Audits, CAPAs, etc. Responsible for implementing changes to quality system documents such as SOPs, WRK and FMEAs. Will be responsible to support regulatory audits of quality systems.
Qualifications
A minimum of a Bachelor's degree in a Life Science, Engineering, or Physical Science or related discipline required. An advanced degree is preferred. A minimum 4 years Medical Device or similar regulated industry experience is required. A minimum of 2 years supervisory experience is required. Working knowledge of and competence in application of FDA (21 CFR Part 820, 803, 804), Health Canada regulations and Medical Device Directive governing complaints and Medical Device Reporting.
Specific understanding of FDA MDR reporting of Medical Device Vigilance reporting is required. Strong communication skills (written and verbal) are required. Strong collaboration, partnership and teamwork across local and global organizations highly desired. Demonstrated proficiency in problem solving skill sets is required. Ability to influence without authority is required
This position is located in Menlo Park and requires negligible travel.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LINA
Primary Location:North America-United States-California-Menlo Park
Organization: Acclarent, Inc. (6206)
Job: Quality (Generalist)
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.