Global Head of Medical Device Safety & PMS Strategy

Carl Zeiss Vision Portugal S.A.; Lisboa; On-site; EUR 120,000 - 180,000; Full time

Job summary

ZEISS Vision Care in Lisbon, Portugal seeks a seasoned leader to own the global Product Safety, Vigilance and Post-Market Surveillance strategy. You will shape governance, align regulatory requirements across EU MDR, US FDA and other markets, and drive data-driven decisions to protect patient and user safety.

You will lead cross-functional teams, manage risk, CAPA, FSCAs, and lifecycle decisions, and advance digital transformation with AI-enabled solutions, while engaging authorities and

Qualifications

• Extensive leadership experience in global Product Safety, Medical Device Vigilance, Post-Market Surveillance (PMS) or Regulatory Affairs.
• Proven ability to define and implement global strategies, governance frameworks and regulatory compliance processes across international markets.
• Strong leadership in geographically distributed teams with accountability for budgets, resources and performance.
• Fluency in English; additional languages and multi-market experience are advantageous.

Responsibilities

• Define and lead the global Product Safety, Vigilance and PMS strategy, governance framework and operating model across international markets.
• Ensure compliance with global regulations and standards, including EU MDR, US FDA requirements, MDSAP and local PMS obligations.
• Oversee incident assessment, reporting decisions, regulatory submissions, trend reporting and communications with authorities.
• Lead identification, evaluation, escalation and mitigation of product safety risks and integrate PMS findings into CAPA and lifecycle decisions.
• Drive PMS data collection, signal detection, trend analysis, data governance and analytics, including AI-enabled solutions.
• Ensure integration of PMS with clinical evaluation, PMCF/PMCS, product development and lifecycle decisions.
• Lead governance and authorization of field safety actions, recalls and responses within delegated authority.
• Lead the global Product Safety and PMS organization, managing people, budgets and capabilities; advise senior management.
• Provide guidance, training and coaching to Local Safety Officers and regional teams.

Skills

Leadership

Regulatory strategy

Medical device safety

Cross-functional leadership

Data analytics

Education

University degree in Life Sciences/Medical Technology/Engineering

Job description

ZEISS Vision Care in Lisbon, Portugal seeks a seasoned leader to own the global Product Safety, Vigilance and Post-Market Surveillance strategy. You will shape governance, align regulatory requirements across EU MDR, US FDA and other markets, and drive data-driven decisions to protect patient and user safety.

You will lead cross-functional teams, manage risk, CAPA, FSCAs, and lifecycle decisions, and advance digital transformation with AI-enabled solutions, while engaging authorities and