Global Post-Market Surveillance Lead, Medical Devices

zeissgroup; Lisboa; On-site; EUR 90,000 - 150,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

Global PMS

Regulatory affairs

Data analysis

Vigilance

Leadership

Cross-functional

Education

Life Sciences / Engineering degree

Job description

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