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

Job Title: Senior Manager of Post Market Safety - Global Product Monitoring (GPM) 

FLSA Status: Exempt 

 

Company Overview 

Insulet started in 2000 driven to achieve our mission of enabling our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients who have insulin-requiring diabetes, by using innovative technology that is wearable, waterproof, and lifestyle accommodating. We are on an exciting trajectory of significant growth and global expansion enabling us to reach more patients around the globe. 

We are looking for highly motivated, performance driven individuals who want to be part of building our Center of Excellence and be at the forefront of our rapidly growing global footprint. We are looking to hire amazing people who are guided by shared values and desire to exceed customer expectations. Our continued success depends on it. 

 

Position Overview 

 

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.  

 

General 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. 

Specific Responsibilities  

• 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. 

Key Decision Rights 

• Consistently exercises judgment and discretion in matters of significant impact to the organization. 

• Proactively leads and communicates with internal groups to gather necessary inputs and facts to execute clear decisions and actions. 

• 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 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.  

Required Leadership/Interpersonal Skills & Behaviors 

• Leads by example and drives the organization's performance with an attitude of continuous improvement by being open to feedback and self-improvement. 

• Inspires trust and followership in others through compelling influence, passion, and active drive. 

• Encourages others to share the spotlight and visibly celebrates and supports the success of the team. 

• Builds strong relationships, demonstrating high emotional intelligence and ability to communicate clearly and persuasively 

• Attracts and recruits top talent, motivates the team, delegates effectively, celebrates diversity within the team, and manages performance; widely viewed as a strong developer of others. 

• Sets clear goals and expectations, tracks progress against the goals, ensures timely feedback, and addresses performance problems and issues promptly. 

• Delegates responsibility and works with others to coach and develop their capabilities. 

• Flexibility in style to bring out the best in people with different backgrounds and working styles, while unifying them in purpose, role clarity, and expectations related to deliverables. 

• Perseveres in the face of challenges and exhibits a steadfast resolve and relentless commitment to higher standards. 

• Comfortable with ambiguity and uncertainty; adapts nimbly and leads others through complex situations. 

• Seeks first to understand, actively listens, and analyzes information and data from a variety of sources to support decisions and to align others with the organization's overall strategy. 

• Effectively handles interactions at all levels and responds appropriately in sensitive situations. 

• Sense of urgency to drive actions in a prioritized manner. 

• Independent motivated self-starter, able to motivate others, and demonstrates a high level of reliability, integrity, and personal accountability. 

• Successively explains complex business and technical topics to both technical and non-technical audiences. 

Required Skills and Competencies 

• 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. 

 

• Preferred Skills and Competencies:           

• Certification in a clinical or patient safety related field. 

 

Education and Experience 

• 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). 

• Preferred Experience: 

• 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. 

Additional Information 

• The position can be hybrid or in-person at our Acton, MA location. The preferred location is to be a commutable distance to Acton, MA.  Will consider candidates that are a commutable distance to other Insulet locations. 

• Travel is estimated at 10-15% but will flex depending on business need. 

• Physical Requirements: General office environment; may sit or stand and use computer for long periods of time.  

 

NOTE: This position is eligible for hybrid working arrangements and requires on-site work from an Insulet office. #LI-Hybrid

Additional Information:

Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $137,900.00 - $206,900.00 This position may also be eligible for incentive compensation. We offer a comprehensive benefits package, including: • Medical, dental, and vision insurance • 401(k) with company match • Paid time off (PTO) • And additional employee wellness programs Application Details: This job posting will remain open until the position is filled. To apply, please visit the Insulet Careers site and submit your application online. Actual pay depends on skills, experience, and education.