Senior Regulatory Affairs Specialist

🔥 41 minutes ago

🇩🇪 Germany – Remote

💵 €63k - €104.9k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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Stryker

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1941

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Stryker is a global leader in medical technology, providing innovative products and services across the healthcare sector. With a presence in countries across the Americas, Asia Pacific, Europe, and the Middle East & Africa, Stryker offers a wide range of medical technologies, including orthopedic implants, surgical equipment, and advanced hospital devices. The company is committed to improving patient outcomes and healthcare efficiency. Stryker continues to expand its global reach, offering localized solutions to meet diverse healthcare needs worldwide.

📋 Description

• Execute post-market surveillance activities focused on Complaint Handling, Product Field Actions (PFA/FSCA), Commercial Holds and related PMS activities • Coordinate intake, processing, follow-up and closure of product complaints with complete and timely quality-system documentation • Coordinate local execution of Product Field Actions, recalls and Commercial Holds, including impact assessment, containment, customer communication, reconciliation, product return/destruction and closure • Review product scope, distribution and inventory information and coordinate required actions with local, regional and divisional stakeholders • Act as operational interface between RAQA, PMS, Legal Manufacturers/Divisions, Customer Service, Sales, Supply Chain, Distribution/Warehouse and other stakeholders • Track outstanding actions, clarify responsibilities and escalate delays, gaps or compliance risks • Support communication with Competent Authorities and external stakeholders • Maintain systems for product complaints, field actions, Commercial Holds and other product-associated events • Monitor case timelines and execution status to ensure completion under applicable procedures • Support complaint trending and monitor the post-market environment • Support development, implementation and improvement of PMS procedures, SOPs, work instructions and training materials • Provide PMS process guidance and operational support to internal stakeholders • Support regulatory inspections, internal and external audits and PMS-related assessments • Prepare and monitor RAQA/PMS metrics and KPIs and identify trends, backlogs and improvement opportunities • Support implementation of PMS process improvements across RAQA

🎯 Requirements

• BSc in Engineering, Science, Regulatory Affairs, Quality Management, Business Administration or related degree; equivalent relevant professional experience may be considered • 2+ years’ relevant experience in Regulatory Affairs, Quality Assurance, Post-Market Surveillance, Complaint Handling or another regulated medical-device environment • Experience working in a cross-functional and international matrix organization preferred • Good understanding of Post-Market Surveillance, Complaint Handling, Vigilance, Product Field Actions/FSCA, recalls and Commercial Holds within the medical-device environment • Strong project, time and priority management skills • Strong problem-solving skills and sound judgement • Strong coordination and stakeholder-management skills • Ability to communicate regulatory and quality requirements to internal and external stakeholders • Ability to review and interpret product, complaint, distribution and quality information • Ability to engage with Competent Authorities and other key stakeholders • High attention to detail, process consciousness and strong documentation skills • Ability to identify process inefficiencies and contribute to continuous improvement and standardization • Strong interpersonal skills • Strong IT skills, including Microsoft Office; experience with quality systems such as TrackWise and reporting tools is advantageous • Fluent in German and English; additional languages are beneficial

🏖️ Benefits

• Incentive compensation may be available, such as bonus and/or commissions where applicable • Stryker’s comprehensive benefits package • Remote or hybrid or onsite work flexibility

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