for Quality and Regulatory Affairs Specialist

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Quality and Regulatory Affairs Specialist
Maastricht, LI 6211 TC, Netherlands
Job details
Work flexibility: Hybrid Req ID: R570330 Employee type: Full Time Job category: RAQA Travel: 10% Relocation: No
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Looking for a place that values your unique talents? Discover Stryker's award-winning culture. Job description
Join a team dedicated to ensuring the safety, quality, and compliance of life-saving medical devices. In this role, you will contribute directly to post-market surveillance and vigilance activities, helping to protect patients while supporting global regulatory compliance. This is an excellent opportunity for an early-career regulatory or quality professional looking to build expertise in medical device regulations and quality systems within a collaborative and mission-driven environment.
What You Will Do - 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.
What You Will Need
Required Qualifications - Bachelor's degree in Engineering, Life Sciences, Regul...