EMEA Post-Market Surveillance Lead

Stryker; Madrid; Hybrid; EUR 44,000 - 73,000; Full time

Benefits offered by this job

Flat hierarchies

Career development

Team engagement

Competitive salary and benefits

Recognition of performance

Employee Resource Groups (ERGs)

Job summary

Stryker is seeking a Regulatory Affairs professional to oversee post‑market surveillance and regulatory reporting across the EMEA region, ensuring medical devices remain safe, compliant, and effective throughout their lifecycle. You will collaborate with regulatory, quality, commercial, and operations teams to drive compliance and continuous improvement.

The role requires a Life Sciences or related degree and a minimum of four years in regulatory affairs or post‑market surveillance, with strong

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 a 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 will be considered a plus.
• Strong communication and interpersonal skills, with a positive, team‑oriented mindset and the ability to remain effective under pressure while managing competing 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 impacted products and customers are accurately identified and managed.
• Manage regulatory notifications and submissions to competent authorities, including responses to requests for additional information.
• Monitor regulatory developments and post‑market surveillance intelligence, maintaining accurate documentation and sharing relevant 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, process adoption, and knowledge sharing across the organization.
• Contribute to process improvement initiatives, system implementations, and integration activities to enhance regional post‑market surveillance effectiveness.

Skills

Regulatory knowledge

Quality assurance

Communication skills

English fluency

Cross-functional collaboration

Education

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

Job description

Stryker is seeking a Regulatory Affairs professional to oversee post‑market surveillance and regulatory reporting across the EMEA region, ensuring medical devices remain safe, compliant, and effective throughout their lifecycle. You will collaborate with regulatory, quality, commercial, and operations teams to drive compliance and continuous improvement.

The role requires a Life Sciences or related degree and a minimum of four years in regulatory affairs or post‑market surveillance, with strong