Senior Specialist Post Market Surveillance
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Job Location:
Monthly Salary:
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
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.
Required Experience:
Senior IC
Key Skills
- Microsoft Access
- SQL
- Analysis Skills
- Microsoft Powerpoint
- Securities Law
- Data Mining
- Investment Banking
- Market Research
- Microsoft Excel
- Visual Basic
- Bloomberg
- Data Analysis Skills
About Company
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more
