Global Head of Medical Device Safety & PMS

ZEISS Group; Lisboa; Sur place; EUR 150 000 - 190 000; Plein temps

Résumé du poste

ZEISS Group in Lisbon, Portugal, invites a seasoned leader to head Global Medical Device Safety & Post-Market Surveillance. You will define global strategy, governance and oversee vigilance, PMS and regulatory compliance across international markets to protect patients and users.

The role drives data-driven transformation, integrates PMS with clinical evaluation, leads field actions, audits readiness and develops talent across the safety organization, partnering with senior management to shape

Qualifications

• Extensive leadership experience in global Product Safety, Medical Device Vigilance, Post-Market Surveillance (PMS) or Regulatory Affairs.
• Proven track record of defining and implementing global strategies, governance frameworks and regulatory compliance processes across international markets.
• 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.

Responsabilités

• Lead the global Product Safety and PMS governance, ensuring regulatory compliance across international markets.
• Define and implement the global strategy for Safety, Vigilance and PMS, integrating post-market findings into lifecycle decisions.
• Oversee incident assessment, reportability decisions, regulatory submissions and trend reporting.
• Drive data collection, signal detection, trend analysis and data governance with advanced analytics and AI-enabled solutions.
• Ensure effective integration of PMS with clinical evaluation, PMCF/PMCS, product development and labeling.
• Lead field safety actions, recalls and crisis management within delegated authority.
• Engage stakeholders and advise senior management on safety, regulatory and lifecycle decisions.
• Coach Local Safety Officers and regional teams to build global capabilities and accountability.
• Prepare for regulatory authority audits and foster continuous improvement of vigilance and PMS processes.

Connaissances

Global strategy

Regulatory affairs

Leadership

Quality systems

Risk management

Vigilance & PMS

Cross-functional collaboration

Data analytics

Regulatory inspections

Formation

Life Sciences / Medical Technology / Engineering degree

Description du poste

ZEISS Group in Lisbon, Portugal, invites a seasoned leader to head Global Medical Device Safety & Post-Market Surveillance. You will define global strategy, governance and oversee vigilance, PMS and regulatory compliance across international markets to protect patients and users.

The role drives data-driven transformation, integrates PMS with clinical evaluation, leads field actions, audits readiness and develops talent across the safety organization, partnering with senior management to shape