Senior Manager – Post-Market Surveillance

Role Overview

• The Post Market Surveillance Senior Manager is responsible for ensuring post-market surveillance processes are compliant, effective, and efficient in line with evolving global regulations.
• Provides governance for procedures and systems and oversees the post-market surveillance program across MedTech franchises, with emphasis on complaint trending, signal detection, data management, and data analysis.
• Leads market engagement to identify insights and opportunities for Customer Quality and Customer Experience Engineering, including processes to support new product launches and acquisitions/integrations.
• Serves as a leading voice in the interpretation of regulatory requirements and advocates for policies and procedures that best support patient safety, proactive regulatory-risk management, and cost efficiency.
• Leads a team of data scientists to develop, maintain, and advance data-analysis methods, processes, tools, systems, and capabilities (including Artificial Intelligence [AI]) used by MedTech post-market surveillance and vigilance teams.
• Supports MedTech franchise post-market surveillance improvements and related corrective and preventive actions, as required.
• Ensures each staff member has clearly established goals and objectives; monitors performance; supports development planning; conducts periodic performance evaluations and compensation planning; and ensures succession planning for key positions, including own.
• Develops, coordinates, and otherwise ensures appropriate training for associates.
• Reviews and continuously leads efforts to improve global post-market surveillance processes.
• Provides tools and procedures that enable rigorous data analysis (e.g., trending of complaint rates over time, part usage, and adverse event rates) and summarizes trends and potential signals, escalating as required.
• Manages stakeholders for processes that consume or provide inputs to post-market surveillance, including executive leadership, medical safety, and other business leaders.
• Oversees the timely completion and delivery of post-market surveillance plans and reports for company products, for use as inputs to technical, safety, and regulatory documentation.
• Oversees methods for analyzing, evaluating, and escalating potential post-market product signals.
• Maintains and continuously improves procedures, processes, and systems for complaint-data analysis and signal detection.
• Responsible for development of signal detection algorithms and data analysis programs.
• Ensures appropriate governance of data analysis quality and documentation of appropriate statistical rationales.
• Continually optimizes data analysis techniques and tools to advance capabilities and efficiency while striving to drive consistency across businesses.
• Ensures support of appropriate post market surveillance related submissions and reports to regulatory agencies worldwide in accordance with Quality System procedures.
• Supports CAPA, compliance, quality, and business objectives by overseeing completion of ad hoc post-market data-analysis projects and queries.
• Provides support during external and internal audits of post-market surveillance processes.
• Remains informed of new or revised regulations and guidelines and assesses impacts on company product-analysis processes.
• Completes detailed gap assessments to internal and external regulations and standards.
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

Requirements

• A minimum of 8 years of related work experience.
• A minimum of 5 years of Quality Assurance experience in the medical device, diagnostic, pharmaceutical, or other regulated industry.
• Previous supervisory/people-management experience.
• Proven ability to work efficiently with general or limited supervision, including in a remote-office environment.
• Demonstrated leadership skills and ability to work in environments with fluctuating and competing priorities.
• Proven advanced critical-thinking skills, including quantitative and qualitative analysis and investigation.
• The ability to understand and follow complex written procedures is required.
• A demonstrated ability to work effectively with cross-functional teams for complaint trend investigation, post market surveillance, root cause analysis, identification and implementation of CAPAs.
• The ability to function in a team environment and deliver on team objectives.
• Demonstrated initiative in delivering strategy objectives, working through ambiguity, meeting deadlines, and developing high-performing teams.
• Ability to influence, drive and manage change.
• Proven leadership in developing and coaching staff.
• Ability to communicate effectively and present clear technical results to non-technical audiences.
• Demonstrates positive CREDO behaviors and demeanor that reflect understanding and support of the organizational values.
• Strong attention to detail.

Benefits

• Retirement plan (pension) and savings plan (401(k))
• Vacation –120 hours per calendar year
• Sick time
• 40 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time
• up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year