EMEA Post‑Market Surveillance Lead (Hybrid)

Stryker; Cork; Hybrid; EUR 54,000 - 90,000; Full time

Benefits offered by this job

Flat hierarchies

Career development

Team engagement

Competitive salary

Recognition of performance

Employee Resource Groups

Job summary

Stryker in Ireland is seeking a Regulatory Affairs professional to lead post‑market surveillance and regulatory reporting across the EMEA region. You will collaborate with regulatory, quality, commercial, and operations teams to ensure devices remain safe, compliant, and traceable throughout their lifecycle.

The role requires a life sciences or engineering degree, at least four years in medical device regulatory affairs or QA, English fluency, and strong communication skills to manage multiple

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, Quality, or a related field.
• Minimum 4 years of experience in Regulatory Affairs, Quality Assurance, Post‑Market Surveillance, or related medical device environment.
• Knowledge of Medical Device Regulations, post‑market surveillance requirements, and quality management systems.
• Experience supporting regulatory reporting, product field actions, complaints, or post‑market surveillance processes.
• Fluency in English; additional languages beneficial.
• Strong communication and interpersonal skills with the ability to manage multiple priorities.

Responsibilities

• Execute post‑market surveillance activities in accordance with applicable regulations, quality requirements, and internal procedures.
• Coordinate product field actions and commercial hold activities across the EMEA region, ensuring identified products and customers are managed.
• Manage regulatory notifications and submissions to competent authorities, including responses to information requests.
• Monitor regulatory developments and post‑market surveillance intelligence, maintaining documentation and sharing updates with stakeholders.
• Support country and regional teams to ensure operational continuity and consistent execution of post‑market surveillance processes.
• Analyze performance data, prepare metrics and reports, and provide insights to support quality and regulatory objectives.
• Develop, update, and deliver training materials to support compliance and knowledge sharing across the organization.
• Contribute to process improvements, system implementations, and integration activities for regional PM surveillance effectiveness.

Skills

Regulatory affairs

Post‑market surveillance

Quality assurance

Regulatory reporting

English fluency

Communication skills

Education

Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, Quality, or related field

Job description

Stryker in Ireland is seeking a Regulatory Affairs professional to lead post‑market surveillance and regulatory reporting across the EMEA region. You will collaborate with regulatory, quality, commercial, and operations teams to ensure devices remain safe, compliant, and traceable throughout their lifecycle.

The role requires a life sciences or engineering degree, at least four years in medical device regulatory affairs or QA, English fluency, and strong communication skills to manage multiple