Sr Director, Global Product Monitoring Safety & Surveillance (Hybrid)

Insulet Corporation•Acton, MA

23d•Hybrid

About The Position

The Senior Director, Global Product Monitoring (GPM) will report directly to the VP of Global Post Market Surveillance and Compliance and be responsible for the development, execution, oversight and maintenance of key aspects of Insulet’s Post Market Surveillance System consistent with applicable laws, industry standards and company policies. They will establish systems, processes and procedures to ensure post market surveillance is optimized to enable effective utilization of product intelligence and resolution of complaint-related and other post-market quality issues. They will partner with other GPM directors, managers, and other functional leaders to manage critical post market operations and identify and prioritize initiatives to drive post market excellence, including ensuring patient safety and regulatory compliance. They are seasoned at people management and responsible for hiring, developing, overseeing, and retaining talent in the GPM teams under their purview and for ensuring seamless coordination across cross-functional teams. They demonstrate the ability to be strategic in quality and operational planning, people leadership, continuous improvement, process design, and program management in a highly regulated, medical technology environment and willingness to perform hands-on, technical and operations work as necessary. They work with local and global cross functional partners and regulatory bodies to ensure effective post market surveillance.

Requirements

Excellent interpersonal, collaboration, negotiation, and leadership abilities, with a track record of driving alignment and fostering cross-functional collaboration.
Change agent able to influence new directions and enable transformational action. Ability to drive teams cross-functionally on compliance-critical initiatives.
Ability to build solid, collaborative working relationships across all functions.
Ability to produce results as a leader, individual contributor, and as a member of a team.
Demonstrated ability to exercise judgment against the criteria of applicable regulations and standards.
Ability to rapidly learn and take advantage of new concepts and technologies. Ability to understand medical/clinical and technical aspects of product. Ability to quickly assimilate relevant information in unfamiliar situations, identify issues and root causes.
Proven analytical, problem-solving, critical thinking, and strategic thinking skills with the ability to synthesize complex data into actionable insights and solutions. Demonstrated ability to use quality engineering principles and problem-solving skills (risk analysis, problem solving methodologies, statistical techniques, etc.) to develop and optimize products/processes that are aligned with overall Quality and Business vision.
Strong working knowledge of the development, application, and measurement of quality performance metrics. Ability to acquire, query and analyze data with focus on detail. Ability to lead, mentor, develop and coordinate activities of staff. Ability to multitask, prioritize effectively and respond to emerging issues, as well as manage team assignments and provide timely direction. Proven ability to consistently meet and/or exceed goals. Capable of making commitments, setting priorities, and delivering results on time and on budget. Ability to prioritize and direct limited resources to the most critical areas and issues.
Excellent written and verbal communication skills; ability to communicate effectively with and influence people at all levels of the organization Strong to expert level knowledge and experience in quality management of medical devices to maintain compliance with 21 CFR 803, 806, & 820, ISO 13485 & 14971, EU MDR, CMDR, and other global regulations, standards, and guidelines (such as MDSAP, IMDRF, MDCG, MEDDEV). Excellent presentation and knowledge transfer skills. Demonstrated ability to implement and maintain accurate documentation consistent with applicable quality standards. Intermediate to advanced computer skills.
BS/BA degree with 12+ years’ work experience with: at least 8 years supervisory/people management experience in the medical devices or life sciences industry; at least 6 years in QA/RA; and at least 4 years leading teams specifically related to medical device post-market surveillance, pharmacovigilance, and/or patient safety. Demonstrated experience in building and leading high-performing, globally distributed teams. Experience managing individuals on a global basis across different locations and cultures. Experience leading and directing middle managers, frontline supervisors, and individual contributors and subject matter experts. Proven experience influencing without authority and facilitating cross-functional collaboration. Applied knowledge of global medical device regulations. Demonstrated experience implementing and ensuring post market processes that meet the requirements of ISO 13485, 21 CFR 820, 21 CFR 803, 21 CFR 806, EU MDR, CMDR, etc. Experience conducting post-market risk assessments (e.g., health hazard assessment) and supporting or leading field actions/advisory notices (e.g., field safety corrective actions, recalls). Experience engaging with regulatory authorities, preferably in the context of post-market requests for additional information.

Nice To Haves

ASQ CQE/CSQE/CQA/CMQOE, RAPS RAC, or equivalent QA/RA certification and/or lean six sigma GB or BB or other process improvement/excellence certification.
eQMS / Quality Information Systems or medical technology/life sciences compliance-critical business systems experience.
General knowledge of diabetes and experience supporting technology related to diabetes.
Quality audits in both a front-room and backroom capacity.
Global vigilance reporting (for example, MDR/MIR).
Total lifecycle product risk management.
CAPAs and quality plans.

Responsibilities

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.
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.