Global Post-Market Surveillance Lead, Medical Devices

Carl Zeiss Vision Portugal S.A.; Lisboa; On-site; EUR 90,000 - 130,000; Full time

Job summary

ZEISS Vision Portugal in Lisbon is seeking a Senior Manager to lead the global Post-Market Surveillance program, ensuring regulatory compliance and driving data-based risk management across products and markets.

The role requires extensive PMS experience, EU MDR and FDA knowledge, and strong leadership with cross-functional collaboration to deliver PSURs, PMS plans, and strategic improvements.

Qualifications

• Extensive experience in global Post-Market Surveillance (PMS) and medical device safety.
• Strong knowledge of EU MDR, FDA requirements and ISO 14971.
• Proven experience developing and implementing global PMS strategies, processes and regulatory reports.
• Experience leading cross-functional teams and regulatory audits.

Responsibilities

• Develop and optimize global PMS strategy, governance, and standards.
• Lead PMS plans, PSURs and regulatory deliverables across markets.
• Ensure compliance with medical device regulations and risk management.
• Drive digital transformation, data quality, and analytics in PMS.
• Collaborate with Quality, Regulatory, Clinical and Engineering teams.

Skills

Leadership

Regulatory affairs

Stakeholder management

Cross-functional leadership

Data analytics

Education

Bachelor's degree in Life Sciences/Engineering

Job description

ZEISS Vision Portugal in Lisbon is seeking a Senior Manager to lead the global Post-Market Surveillance program, ensuring regulatory compliance and driving data-based risk management across products and markets.

The role requires extensive PMS experience, EU MDR and FDA knowledge, and strong leadership with cross-functional collaboration to deliver PSURs, PMS plans, and strategic improvements.