Global PMS Senior Manager, Medical Devices

ZEISS Group; Lisboa; On-site; EUR 90,000 - 130,000; Full time

Job summary

ZEISS Group in Lisbon, Portugal, seeks a Senior Manager, Global Post-Market Surveillance to lead global PMS governance and improve safety pathways across markets.

You will shape PMS strategies, ensure regulatory compliance (EU MDR, FDA, ISO 14971), and drive data-driven risk mitigation with analytics and digital tooling. The role interfaces with Quality, Regulatory, Clinical and Engineering to enable proactive product safety decisions.

Qualifications

• Extensive experience in global Post-Market Surveillance (PMS) and regulatory affairs.
• Strong knowledge of EU MDR, FDA requirements and ISO 14971.
• Proven experience developing global PMS strategies, processes and regulatory reports, including PSURs.
• Expertise in post-market data analysis, signal detection, trend monitoring and risk assessment.
• Strong understanding of complaint management, CAPA, risk management and lifecycle processes.
• Experience supporting regulatory audits, inspections, recalls and field actions.
• Proven ability to lead global projects, drive harmonization and continuous improvement.
• Experience in PMS data management, digitalization and advanced analytics is an advantage.
• Demonstrated ability to influence cross-functional stakeholders in international organizations.
• Fluent English communication of regulatory and technical topics.

Responsibilities

• Develop and continuously improve the global PMS strategy, governance, processes and standards.
• Lead the development, implementation and maintenance of PMS plans, reports and regulatory deliverables.
• Ensure global PMS compliance with applicable medical device regulations and standards.
• Establish robust processes for data collection, analysis, trend monitoring and signal detection.
• Identify emerging product safety risks and provide data-driven risk mitigation recommendations.
• Integrate PMS findings into risk management, complaints, CAPA and lifecycle decisions.
• Support product safety investigations, health hazard evaluations, recalls and field actions.
• Provide regulatory expertise and support audits, inspections and submissions.
• Drive PMS digital transformation, data quality, automation and advanced analytics.
• Develop global PMS training and act as a subject matter expert.

Skills

Global PMS experience

Regulatory affairs knowledge

EU MDR / FDA / ISO 14971 knowledge

PMS strategy development

Data analysis and signal detection

Complaint management and CAPA

Risk management and lifecycle

Regulatory audits and inspections

Cross-functional leadership

Fluent English

Education

Relevant university degree in Life Sciences, Engineering, Medical Technology or related discipline

Job description

ZEISS Group in Lisbon, Portugal, seeks a Senior Manager, Global Post-Market Surveillance to lead global PMS governance and improve safety pathways across markets.

You will shape PMS strategies, ensure regulatory compliance (EU MDR, FDA, ISO 14971), and drive data-driven risk mitigation with analytics and digital tooling. The role interfaces with Quality, Regulatory, Clinical and Engineering to enable proactive product safety decisions.