Regulatory & Quality Specialist — Post-Market

Stryker; Maastricht; Hybride; EUR 42 000 - 78 000; Plein temps

Avantages offerts par ce poste

Flat hierarchies

Career development

Competitive salary and benefits

Recognition programs

Inclusive, collaborative environment

Career progression opportunities

Résumé du poste

Stryker is seeking a regulatory/post-market surveillance professional to contribute to vigilance activities and ensure compliance across global regulatory requirements. You will review complaints for reportability, manage investigations, and prepare regulatory submissions in a collaborative, mission-driven environment.

The role requires a bachelor’s degree in engineering or life sciences, English fluency, and familiarity with quality systems and regulatory frameworks such as EU MDR, 21 CFR Part

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Regulatory Science, or a related field.
• proficiency with computer-based systems and common business software applications.
• Fluent in English (written and spoken).

Responsabilités

• 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.
• Maintain systems and records used to monitor, track, and report product complaints and adverse events.
• Collaborate with investigators, local teams, customers, and regulators for reportability assessments and investigations.
• Support audits, field actions, recalls, nonconformance investigations, and CAPA activities.

Connaissances

Regulatory affairs

Post-market surveillance

Complaint handling

Vigilance reporting

English communication

Formation

Bachelor’s degree in Engineering

Bachelor’s degree in Life Sciences

Regulatory Science degree

Description du poste

Stryker is seeking a regulatory/post-market surveillance professional to contribute to vigilance activities and ensure compliance across global regulatory requirements. You will review complaints for reportability, manage investigations, and prepare regulatory submissions in a collaborative, mission-driven environment.

The role requires a bachelor’s degree in engineering or life sciences, English fluency, and familiarity with quality systems and regulatory frameworks such as EU MDR, 21 CFR Part