Manager, Product Monitoring NeuroPace
THIS JOB HAS EXPIRED Job Description:
The Product Monitoring Manager will establish and maintain the systems necessary to evaluate product complaints and product performance feedback, manage product investigations and communicate event investigation results to regulatory agencies and NeuroPace management. This system is governed by complaint handling and reporting requirements as defined in 21 CFR 820, ISO 13485:2003, 21 CFR 820.803, and other global governmental regulations.
Develop internal systems, methods, and procedures to maintain compliance and support post-market surveillance activities. Evaluate and recommend changes to current systems.
Manage receipt and documentation of product events reported by customers and field representatives. Manage complaint investigations, including gathering sufficient data from internal technical personnel, clinical staff, NeuroPace field representatives, and clinicians.
Assess product complaints for regulatory reportability and potential impact to patient safety and business operations. Complete and submit regulatory reports within the timeframes mandated by the FDA.
Support Authorized Representative activities including Vigilance reporting within the timeframes mandated by the regulatory authorities.
Trend complaint data and maintain complaint and MDR files that meet the QSR and business requirements. Conduct periodic post-market safety reviews for commercially distributed products.
Educate and train clinical and field personnel on the proper method of reporting product complaints and product performance feedback.
Prepare for and participate in FDA inspections and Notified Body audits.
Hire, train and provide guidance to staff as needed.
Bachelors Degree, preferably in a science field, and a minimum of seven years of related work experience.
Direct experience in medical device complaint handling and regulatory reporting, both in the US (MDR) and in the global market with increasing levels of responsibility; demonstrated solid understanding of reporting requirements and industry standards.
Advanced oral and written communication skills. Demonstrated ability to provide effective leadership to cross-functional teams.
Highly skilled in use of computer system applications for data collection, analysis and charting.
NeuroPace is an equal opportunity employer offering a competitive compensation and benefits package including medical, dental, vision, 401(k), and stock options.
||1375 Shorebird Way |
Mountain View, CA 94043
THIS JOB HAS EXPIRED