Head of Global Medical Device Safety & Post-Market Surveillance
ZEISS · Lisbon
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 Head of Global Medical Device Safety & Post Market Surveillance to join us in Lisbon, Portugal.
Your Role
Lead the global Medical Device Safety, Vigilance and Post-Market Surveillance (PMS) strategy for ZEISS Vision Care, ensuring regulatory compliance and proactive management of product safety risks across international markets. Establish effective global governance, processes and systems to identify, assess and mitigate risks throughout the product lifecycle. Provide strategic leadership, expert regulatory guidance and cross-functional direction, while driving data-driven decision-making, digital transformation and continuous improvement to protect patient and user safety.
The role of Head of Global Medical Device Safety & Post Market Surveillance will involve:
- Global Strategy & Governance: Define and lead the global Product Safety, Vigilance and PMS strategy, governance framework and operating model across international markets.
- Regulatory Compliance: Ensure compliance with applicable global regulations and standards, including EU MDR, US FDA requirements, MDSAP and local vigilance and PMS obligations.
- Vigilance & Reporting: Oversee incident assessment, reportability decisions, regulatory submissions, trend reporting and timely communication with competent authorities.
- Product Safety & Risk Management: Lead the identification, evaluation, escalation and mitigation of product safety risks, integrating post-market findings into risk management, CAPA and lifecycle decisions.
- PMS Data & Digital Transformation: Drive robust post-market data collection, signal detection, trend analysis, data governance, automation and advanced analytics, including appropriate AI-enabled solutions.
- Clinical Evidence & Lifecycle Management: Ensure effective integration of PMS with clinical evaluation, PMCF/PMCS, product development, design changes, labelling and product lifecycle decisions.
- Field Actions & Crisis Management: Lead the governance and authorization of field safety corrective actions (FSCAs), recalls and product safety responses within delegated authority.
- Leadership & Stakeholder Engagement: Lead the global Product Safety and PMS organization, managing people, budgets, resources and capabilities while advising senior management and cross-functional stakeholders.
- Training & Capability Development: Provide expert guidance, training and coaching to Local Safety Officers and regional teams, strengthening global competencies and accountability.
- Regulatory Engagement & Audit Readiness: Lead or support regulatory authority interactions, inspections and audits, ensuring effective remediation and continuous improvement of vigilance and PMS processes.
Your Experience
- Extensive leadership experience in global Product Safety, Medical Device Vigilance, Post-Market Surveillance (PMS) or Regulatory Affairs within the medical device or MedTech industry.
- Proven track record of defining and implementing global strategies, governance frameworks and regulatory compliance processes across international markets.
- Demonstrated experience leading and developing high-performing, geographically distributed teams, with responsibility for people, budgets, resources and organizational performance.
- Strong expertise in global medical device regulations, including EU MDR, US FDA requirements, MDSAP and applicable vigilance and PMS standards.
- Proven ability to influence executive leadership and drive cross-functional decisions within complex international matrix organizations.
- Experience managing critical product safety events, regulatory inspections, recalls and business-critical risk assessments.
- Strong background in product risk management, signal detection, incident reporting and integration of PMS findings into CAPA and product lifecycle decisions.
- Experience driving organizational transformation, digitalization, data analytics and continuous improvement initiatives.
- Demonstrated ability to develop talent, build organizational capabilities and establish clear accountability across corporate, regional and local teams.
- Excellent strategic thinking, stakeholder management, communication and decision-making skills, with the ability to translate complex regulatory and safety issues into actionable business recommendations.
- Relevant university degree in Life Sciences, Medical Technology, Engineering or a related discipline.
- Fluency in English; additional languages and experience working across global markets are advantageous.
Apply now to take the next step in joining ZEISS, where you can push technological boundaries, shape markets and contribute to the advancement of society.
Your ZEISS Recruiting Team:
Kate Campbell