Sr Director, Global Product Monitoring Safety & Surveillance (Hybrid)
Insulet Corporation, Acton, Massachusetts, us, 01720
* Serves as a strong mentor, coach, people manager, leader, and subject matter expert in post-market surveillance (particularly, in post-market safety and productive engagement with regulatory authorities on post-market matters) providing both strategic and tactical direction to support growth, maintain compliance, and drive toward post-market excellence.* Directs a global, high-performance team focused on post-market safety, surveillance, and compliance while driving a culture of excellence and strategic post-market programs and processes for the organization.* Leads people managers and individual contributors, ensuring they are effective, efficient, assisted, and supported to succeed in their roles and their continual professional development. Ensures their selection, orientation, development, and retention to carry out their responsibilities. Conducts performance appraisals and ensures development opportunities for staff.* Maintains training and job requirements for personnel, including job descriptions/profiles, and ensures their training is completed by established due dates.* Develops and maintains product knowledge of existing and new products and ensures team members do the same.* Engages globally with internal and external stakeholders, developing and maintaining strong relationships to ensure effective processes while identifying improvements to drive efficiency and compliance.* Represents GPM at cross-functional, multi-level, and external meetings.* Drives operational excellence by helping to ensure that post-market surveillance processes and practices reflect industry best practices. Develops and maintains a culture of continuous process improvement.* Adheres to all regulatory compliance and quality standards, including company policies and procedures and U.S. FDA, Health Canada, EU MDR, and other applicable quality system and country-specific regulations, and establishes, maintains and promotes a culture of quality with a keen focus on patient safety and customer experience.* Maintains awareness of new or revised regulations, standards, and/or guidelines, particularly as they pertain to post-market vigilance and surveillance. Reviews changes in international laws and regulations and assesses their impact and makes recommendations to ensure compliance.* Interfaces with notified bodies and regulatory authorities as necessary, particularly in the context of vigilance reporting, RFAIs, field actions, and audits.* Reviews, evaluates and approves document changes, especially those concerning significant changes and revisions.* Provides front-room and/or back-room leadership and support during inspections by regulatory authorities (such as competent authorities and notified bodies).* Ensures follow-up on activities related to internal and external QMS audits, managing and resolving any nonconformances or other findings.* Ensures required documentation, records, and reports are complete, accurate, and properly maintained.* Monitors, identifies, manages, and escalates critical events, quality/safety signals, and trends and works with cross-functional partners to drive response and improvement based on post market feedback. Implements prompt actions as necessary to ensure product safety and effectiveness.* Ensures all appropriate levels of leadership are informed of any significant concerns, action plans, and status, driving organizational awareness of key post market issues and signals.* Identifies process improvement opportunities and, where needed, leads corrective and preventive actions (CAPAs) and other process improvements.
Works closely with internal and external stakeholders to drive the initiation of process NCs, CAPAs and supplier corrective actions (SCARs) when appropriate. Provides support or leadership to global expansion efforts.* Ensures key performance indicators are met or exceeded and works to continually drive down time-to-detect and time-to-resolve through improved detection and rapid response.* Performs other duties as required.* Reports to the Vice President, Global Post Market Surveillance & Compliance.* Oversee global post-market professionals responsible for the timely and effective management, preparation, and assembly of information for post-market requests for additional information (RFAIs) or other authority inquiries related to marketed products.
Help write these responses and facilitate engagement or engage with regulatory authorities as needed.
Author and/or approve response communications to inquiries and requests from regulatory authorities around the world.* Direct and ensure back-up of the French local contact for vigilance (matériovigilance) and oversee transmission of French incidents to the French local contact for matériovigilance.* Lead, mentor, and further develop a product/patient safety capability that applies clinical experience across the entire post market surveillance system, such as by: (a) advising on clinical/technical content in vigilance reports; (b) performing customer follow-up actions related to critical complaints;
(c) providing clinical/compliance writing support of public health risk assessments (PISCEs), periodic safety reporting (e.g., PSUR, CSR), and, in collaboration with Clinical Affairs, post-market clinical follow-up (PMCF); (d)
authoring/co-authoring post-market plans and reports (such as, PMS plans, PSURs/PMSRs, Canadian summary reports, PMCF plans, PMCF evaluation reports, and equivalent plans and reports for other global markets); (e) serving as subject matter experts to promote and augment awareness across the company and helping to sustain integration of post-market surveillance, patient safety, total lifecycle risk management, and clinical evaluation practices across the organization; and (f) driving collaboration with Clinical Affairs, Medical Affairs, Regulatory Affairs, Design Assurance, Product Support, Customer Care, Legal, and other functional areas, to enable an integrated holistic total lifecycle risk management/patient safety strategy applied to commercial products.* Maintain and/or utilize reports and dashboards to identify and manage post-market safety, surveillance, and compliance activities.* Where appropriate, ensure escalation and cross-functional engagement with stakeholders around the world to enable rapid response to emerging issues and opportunities.* Provides independent assurance that sound post market surveillance sub-processes are maintained and continuously improved to support outstanding customer experience and growth of the business.* Consistently exercises independent judgment and discretion in matters of significant impact to the organization.* Establishes, maintains and promotes a strategy for compliance with quality objectives and requirements.* Proactively leads and communicates with internal groups to gather necessary inputs and facts to execute clear decisions and actions, including driving prioritization of product intelligence insights gained through post market feedback.* Collaborates with internal groups to provide relevant and critical clinical and technical information to help identify product improvement opportunities.* Identifies risk exposures that may impact the achievement of company objectives.* Makes sound decisions with reasonable foresight as to potential risks, alternatives, and benefits.* Assists in risk assessments as needed in collaboration with Medical Affairs, R&D, and other internal experts.* Provides input to conclusions to be included in complaint files, regulatory reports, RFAIs, and/or other regulatory authority-facing records.* Self-reflective and aware of his/her own limitations; leads by example and drives the organization's performance with an attitude of continuous improvement by being open to feedback and self-improvement.* Builds competitive advantage by assembling a high-performing team.* Inspires trust and followership in others through compelling influence, passion #J-18808-Ljbffr
Works closely with internal and external stakeholders to drive the initiation of process NCs, CAPAs and supplier corrective actions (SCARs) when appropriate. Provides support or leadership to global expansion efforts.* Ensures key performance indicators are met or exceeded and works to continually drive down time-to-detect and time-to-resolve through improved detection and rapid response.* Performs other duties as required.* Reports to the Vice President, Global Post Market Surveillance & Compliance.* Oversee global post-market professionals responsible for the timely and effective management, preparation, and assembly of information for post-market requests for additional information (RFAIs) or other authority inquiries related to marketed products.
Help write these responses and facilitate engagement or engage with regulatory authorities as needed.
Author and/or approve response communications to inquiries and requests from regulatory authorities around the world.* Direct and ensure back-up of the French local contact for vigilance (matériovigilance) and oversee transmission of French incidents to the French local contact for matériovigilance.* Lead, mentor, and further develop a product/patient safety capability that applies clinical experience across the entire post market surveillance system, such as by: (a) advising on clinical/technical content in vigilance reports; (b) performing customer follow-up actions related to critical complaints;
(c) providing clinical/compliance writing support of public health risk assessments (PISCEs), periodic safety reporting (e.g., PSUR, CSR), and, in collaboration with Clinical Affairs, post-market clinical follow-up (PMCF); (d)
authoring/co-authoring post-market plans and reports (such as, PMS plans, PSURs/PMSRs, Canadian summary reports, PMCF plans, PMCF evaluation reports, and equivalent plans and reports for other global markets); (e) serving as subject matter experts to promote and augment awareness across the company and helping to sustain integration of post-market surveillance, patient safety, total lifecycle risk management, and clinical evaluation practices across the organization; and (f) driving collaboration with Clinical Affairs, Medical Affairs, Regulatory Affairs, Design Assurance, Product Support, Customer Care, Legal, and other functional areas, to enable an integrated holistic total lifecycle risk management/patient safety strategy applied to commercial products.* Maintain and/or utilize reports and dashboards to identify and manage post-market safety, surveillance, and compliance activities.* Where appropriate, ensure escalation and cross-functional engagement with stakeholders around the world to enable rapid response to emerging issues and opportunities.* Provides independent assurance that sound post market surveillance sub-processes are maintained and continuously improved to support outstanding customer experience and growth of the business.* Consistently exercises independent judgment and discretion in matters of significant impact to the organization.* Establishes, maintains and promotes a strategy for compliance with quality objectives and requirements.* Proactively leads and communicates with internal groups to gather necessary inputs and facts to execute clear decisions and actions, including driving prioritization of product intelligence insights gained through post market feedback.* Collaborates with internal groups to provide relevant and critical clinical and technical information to help identify product improvement opportunities.* Identifies risk exposures that may impact the achievement of company objectives.* Makes sound decisions with reasonable foresight as to potential risks, alternatives, and benefits.* Assists in risk assessments as needed in collaboration with Medical Affairs, R&D, and other internal experts.* Provides input to conclusions to be included in complaint files, regulatory reports, RFAIs, and/or other regulatory authority-facing records.* Self-reflective and aware of his/her own limitations; leads by example and drives the organization's performance with an attitude of continuous improvement by being open to feedback and self-improvement.* Builds competitive advantage by assembling a high-performing team.* Inspires trust and followership in others through compelling influence, passion #J-18808-Ljbffr