Senior Specialist Post Market Surveillance

Work Flexibility: Hybrid

The Senior Post Market Specialist will lead complex assignments within global regulatory frameworks, applying advanced expertise in Post Market Surveillance (PMS). This role requires technical ownership, leadership through expertise, and collaboration across functions to strengthen PMS effectiveness.

The ideal candidate will have strong experience in PMS data trending and statistical analysis, with the ability to enhance and advance existing methodologies. The role focuses on detecting, interpreting, and communicating trends and signals from complaint, quality, and clinical data to ensure product safety and compliance.

Key Responsibilities

• Apply sound knowledge of Vigilant processes, complaint handling, and reportability to support effective PMS activities.

• Generate and interpret performance data from TrackWise or other complaint-handling systems

• Design, perform, and continuously improve statistical trending approaches for PMS data, ensuring robustness, accuracy, and early signal detection

• Create and maintain Post Market Surveillance documents in accordance with regulatory requirements (EU 2017/745, MDD 92/42/EWG, ISO 13485, FDA, Health Canada, etc.)

• Develop PMS Plans (PMSPs), PMS Reports (PMSRs), and Periodic Safety Update Reports (PSURs), including corresponding updates

• Lead proactive PMS activities (e.g., web screening, MAUDE searches, customer surveys, registry analyses)

• Collaborate with Clinical, Marketing, Medical Affairs, Regulatory Affairs, and R&D teams to collect and evaluate feedback

• Provide technical leadership and mentorship on PMS methodologies, trending practices, and data interpretation

• Identify and drive process improvements and innovation in PMS and statistical analysis methods

• Develop and maintain SOPs and work instructions related to PMS and trending activities

• Review and approve PMS and PMCF documentation independently in OnePLM

• Support Notified Body interactions and deficiency letter responses

• Lead coordination and alignment between PMS workstreams and related functions

Education / Work Experience:

• BS in Engineering, Science, or related degree; or MS in Regulatory Science

• 2-4 years’ experience

Knowledge/Competencies:

• Demonstrates advanced organizational and time management skills to prioritize complex projects and meet deadlines with minimal supervision.
• Possesses in-depth knowledge of Post Market Surveillance (PMS) regulations and applies them independently, ensuring compliance across multiple product lines.
• Expert understanding of Complaint Handling and Adverse Event Reporting processes, including global regulatory requirements, and provides guidance to others.
• Applies strong analytical and critical thinking skills to interpret large datasets, identify emerging trends, and recommend proactive risk mitigation strategies.
• Communicates effectively and persuasively with cross-functional teams, management, and external stakeholders, adapting messaging for different audiences.
• Leads the preparation of detailed reports, briefings, and regulatory submissions, ensuring accuracy and strategic alignment.
• Collaborates across departments as a subject matter expert, proactively resolving issues and driving continuous improvement initiatives.
• Demonstrates leadership in problem-solving, mentoring junior team members and fostering a culture of quality and compliance.
• Shows initiative and accountability, managing complex tasks and projects with minimal oversight while maintaining high attention to detail.
• Integrates feedback constructively, using insights to optimize processes and enhance team performance.
• Champions innovation and process improvements, leveraging new tools, systems, and methodologies to strengthen PMS activities.
• Builds strong relationships across diverse teams, promoting collaboration and influencing decision-making.
• Confidently represents PMS during audits and inspections, explaining processes and defending compliance positions with authority.

Travel Percentage: 20%