Sr Manager, Post Market Safety - Global Product Monitoring (Hybrid - Acton, MA)

Insulet Corporation•Acton, MA

13d•Hybrid

About The Position

The Senior Manager, Post-Market Safety-Global Product Monitoring (GPM) will report directly to the Senior Director of GPM-Safety & Surveillance 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 are seasoned at people management and responsible for hiring, developing, overseeing, and retaining talent in the GPM Safety team. They demonstrate the ability to execute 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 to ensure effective post market safety and surveillance.

Requirements

Proven ability to: Build solid, collaborative working relationships across all functions.
Produce results as a leader, individual contributor, and as a member of a team.
Exercise judgment against the criteria of applicable regulations and standards.
Rapidly learn and take advantage of new concepts and technologies.
Understand medical/clinical and technical aspects of product.
Quickly assimilate relevant information in unfamiliar situations, identify issues and root causes.
Proven analytical, problem-solving, and critical thinking skills with the ability to synthesize complex data into actionable insights and solutions.
Acquire, query and analyze data with focus on detail.
Lead, mentor, develop and coordinate activities of staff.
Respond to emerging issues, manage team assignments, and provide timely direction.
Prioritize and direct limited resources to the most critical areas and issues.
Make commitments, set priorities, and deliver results on time and on budget
Communicate effectively with and influence people at all levels of the organization
Present and transfer knowledge.
Implement and maintain accurate documentation consistent with applicable quality standards.
Fluency in applicable regulations and standards.
Intermediate to advanced computer skills.
BS/BA degree with 8+ years’ work experience with:
at least 3 years’ people management experience in the MedTech/Life Sciences industry; and
at least 4 years’ experience in patient safety, post-market surveillance, pharmacovigilance, and/or medical information in the MedTech/Life Sciences industry.
Demonstrated experience in building and leading high-performing, globally distributed teams.
Experience managing individuals on a global basis across different locations and cultures.
Experience influencing without authority and facilitating cross-functional collaboration.
Proven 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).

Nice To Haves

Certification in a clinical or patient safety related field.
In addition to the above, at least a general knowledge of:
diabetes and experience supporting technology and/or medicines related to diabetes.
global vigilance reporting requirements.
total lifecycle product risk management in the medical devices industry.
SAMD and SIMD.

Responsibilities

Serves as a mentor, coach, people manager, leader, and subject matter expert in post-market safety providing tactical and operational direction to support growth, maintain compliance, and drive toward post-market excellence.
Directs a small but global team focused on post-market safety while driving a culture of excellence and cross-functional collaboration.
Establishes, maintains and promotes a culture of quality with a keen focus on patient safety and customer experience.
Leads 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 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.
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.
Maintains awareness of new or revised regulations, standards, and/or guidelines, particularly as they pertain to post-market safety and surveillance.
Reviews, evaluates and approves document changes, especially those concerning significant changes and revisions.
Ensures required documentation, records, and reports are complete, accurate, and properly maintained.
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 Senior Director of GPM-Safety & Surveillance.
Advise on clinical/technical content in vigilance reports.
Perform customer follow-up actions related to critical, high-impact complaints.
Lead and coauthor the writing of post market risk assessments (HHEs).
Contribute to the authorship of 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).
Serve as subject matter expert and lead adoption of best practices to sustain integration of post-market surveillance, patient safety, total lifecycle risk management, and clinical evaluation practices across the organization and to help to enable an integrated holistic total lifecycle risk management/patient safety strategy applied to commercial products.
Where appropriate, ensure escalation and cross-functional engagement with stakeholders around the world to enable rapid response to emerging issues and opportunities.
Directly manage a global team of Post Market Safety Specialists responsible for the above.