Post-Market Regulatory & Quality Specialist

Stryker Corporation; Maastricht; Hybrid; EUR 42,000 - 78,000; Full time

Benefits offered by this job

Salary and benefits package

Career development

Job summary

Stryker Corporation is hiring for a regulatory/post-market surveillance professional in the Netherlands. The role focuses on review of complaints, vigilance reporting, and regulatory compliance across audits and investigations in a hybrid work setting with occasional travel.

Requirements include a bachelor’s degree in a relevant field, English fluency, and 1+ year in regulatory or quality roles within medical devices or related regulated industries.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Regulatory Science, or related field.
• Proficiency with computer-based systems and standard business software applications.
• Fluent in English (written and spoken).
• Minimum 1 year of experience in Regulatory Affairs, Quality Assurance, Post-Market Surveillance, Complaint Handling, Medical Device Vigilance, or related regulated environment.

Responsibilities

• Review product complaints and assess regulatory reportability within established timelines.
• Manage complaint handling activities, including documentation, tracking, and follow-up actions.
• Review and approve complaint investigations to support timely and compliant resolution.
• Prepare and submit initial and follow-up vigilance reports to regulatory authorities in accordance with applicable requirements.
• Maintain systems and records used to monitor, track, and report product complaints and adverse events.
• Partner with investigators, local teams, customers, and regulatory agencies to collect information required for reportability assessments and investigations.
• Support audits, field actions, recalls, nonconformance investigations, and corrective and preventive action activities to maintain compliance.
• Contribute to the development and maintenance of regulatory procedures, standard operating procedures, and post-market surveillance processes.

Skills

English fluency

Regulatory knowledge

Education

Bachelor’s degree in Engineering, Life Sciences, Regulatory Science, or related field

Tools

Computer software proficiency

Job description

Stryker Corporation is hiring for a regulatory/post-market surveillance professional in the Netherlands. The role focuses on review of complaints, vigilance reporting, and regulatory compliance across audits and investigations in a hybrid work setting with occasional travel.

Requirements include a bachelor’s degree in a relevant field, English fluency, and 1+ year in regulatory or quality roles within medical devices or related regulated industries.