Senior Manager Medical Device Safety & Post-Market Surveillance

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 is technology and innovation. Founded in Germany, in 1846, ZEISS is an internationally leading technology enterprise operating in the optics and optoelectronics industries across 50 countries.

As a company wholly owned by a foundation, ZEISS is committed to responsibility in all its activities. As a pioneer in scientific optics, it’s employees across the globe continue to push the boundaries of what is possible. With a strong focus on quality and innovation, ZEISS creates value for its customers and helps shape new ways of seeing the world.

We’re looking for a Senior Manager. Global Post-Market Surveillance to join us in Lisbon, Portugal.

Your Role

The Senior Manager Global Post-Market Surveillance (PMS) is responsible for the global execution, governance and continuous improvement of the ZEISS Vision Care Post-Market Surveillance system across products and markets.

The role ensures that post-market information is systematically collected, assessed, analyzed and translated into actionable product safety, risk management, regulatory, quality and lifecycle decisions.

The Senior Manager leads the development and implementation of risk-based PMS strategies, surveillance methodologies, signal detection, PMS plans and reports, ensuring compliance with applicable global regulatory requirements, including EU MDR, US FDA, MDSAP and relevant local market requirements.

The role serves as a global PMS subject matter expert and key interface between Global Product Safety, Quality, Regulatory Affairs, Clinical/Medical Affairs, Complaint Management, CAPA, Risk Management, Product Development, Operations and regional/local organizations.

The Senior Manager drives standardization, data quality, digitalization and analytical capabilities across the global PMS organization and provides expert support during significant product safety events, regulatory inspections, audits and field actions.

The role of Senior Manager. Medical Device Safety & Post Market Surveillance will involve:

• Develop and continuously improve the global PMS strategy, governance, processes and standards.
• Lead the development, implementation and maintenance of PMS plans, reports, PSURs and other regulatory deliverables.
• Ensure global PMS compliance with applicable medical device regulations and standards.
• Establish robust processes for post-market data collection, analysis, trend monitoring and signal detection.
• Identify emerging product safety risks and provide data-driven recommendations for risk mitigation.
• Integrate PMS findings into risk management, complaints, CAPA, clinical evaluation and product lifecycle decisions.
• Support product safety investigations, health hazard evaluations, recalls and field safety corrective actions.
• Provide regulatory expertise and support audits, inspections and regulatory submissions.
• Drive PMS digital transformation, data quality, automation, advanced analytics and AI-enabled surveillance.
• Develop global PMS training, guidance and competency programs, acting as a subject matter expert.
• Lead global cross-functional projects and collaborate with Quality, Regulatory Affairs, Clinical, Engineering and other stakeholders.
• Promote harmonization, continuous improvement and a proactive, risk-based product safety culture across global markets.

Your Experience

• Extensive experience in global Post-Market Surveillance (PMS), medical device safety, vigilance or regulatory affairs within the medical device or MedTech industry.
• Strong knowledge of global medical device regulations and standards, including EU MDR, FDA requirements and ISO 14971.
• Proven experience developing and implementing global PMS strategies, processes, plans and regulatory reports, including PSURs and PMSRs.
• Expertise in post-market data analysis, signal detection, trend monitoring, product risk assessment and benefit-risk evaluation.
• Strong understanding of complaint management, CAPA, risk management, clinical evaluation and product lifecycle processes.
• Experience supporting regulatory audits, inspections, product safety investigations, recalls and field safety corrective actions.
• Proven ability to lead global projects, drive process harmonization and implement continuous improvement initiatives.
• Experience in PMS data management, digitalization, automation and advanced analytics is an advantage.
• Demonstrated ability to influence and collaborate with cross-functional stakeholders across international, matrix organizations.
• Strong leadership, stakeholder management, communication and decision-making skills, with the ability to develop global capabilities and drive change.
• A relevant university degree in Life Sciences, Engineering, Medical Technology or a related discipline.
• Fluent English, with the ability to communicate complex regulatory and technical topics clearly to diverse audiences.