Senior Manager Medical Device Safety & Post-Market Surveillance

Zeissgroup; Lisboa; Sur place; EUR 90 000 - 150 000; Plein temps

Résumé du poste

ZEISS in Lisbon is seeking a Senior Manager, Global Post-Market Surveillance to lead worldwide PMS governance, data analytics and regulatory reporting for medical devices. You will partner with Quality, Regulatory, Clinical and Product teams to standardize processes, drive digital transformation and ensure EU MDR, FDA and ISO 14971 compliance across markets.

Fluent English and a Life Sciences/Engineering degree are required; experience with PSURs, PMSRs and risk management is essential for

Qualifications

• Extensive experience in global Post-Market Surveillance (PMS) and medical device safety.
• Strong knowledge of EU MDR, FDA requirements and ISO 14971.
• Experience developing and implementing global PMS strategies, processes, plans and regulatory reports (PSURs/PMSRs).
• Experience in PMS data management, digitalization, automation and advanced analytics is an advantage.
• Fluent English with ability to communicate regulatory/technical topics clearly.

Responsabilités

• 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 actions.
• Provide regulatory expertise and support audits, inspections and regulatory submissions.
• Drive PMS digital transformation, data quality, automation and advanced analytics.

Connaissances

Global PMS

Regulatory affairs

Data analysis

Vigilance

Leadership

Cross-functional

Formation

Life Sciences / Engineering degree

Description du poste

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.