Senior Regulatory Affairs Specialist

This is a fully remote position, open to applicants in Germany.

📋 Description

• Carry out post-market surveillance tasks with a focus on Complaint Management, Product Field Actions (PFA/FSCA), Commercial Holds, and related PMS activities.

• Oversee the intake, processing, follow-up, and resolution of product complaints, ensuring complete and timely documentation within the quality system.

• Manage the local execution of Product Field Actions, recalls, and Commercial Holds, which includes impact assessment, containment, customer communication, reconciliation, product return/destruction, and closure.

• Evaluate product scope, distribution, and inventory data, coordinating necessary actions with local, regional, and divisional stakeholders.

• Serve as the operational liaison among RAQA, PMS, Legal Manufacturers/Divisions, Customer Service, Sales, Supply Chain, Distribution/Warehouse, and other relevant stakeholders.

• Monitor outstanding actions, clarify responsibilities, and escalate any delays, gaps, or compliance risks.

• Assist in communication with Competent Authorities and external stakeholders.

• Maintain systems for product complaints, field actions, Commercial Holds, and other product-related events.

• Supervise case timelines and execution status to ensure compliance with applicable procedures.

• Aid in complaint trend analysis and monitor the post-market environment.

• Support the development, implementation, and enhancement of PMS procedures, SOPs, work instructions, and training materials.

• Offer PMS process guidance and operational assistance to internal stakeholders.

• Assist with regulatory inspections, internal and external audits, and PMS-related evaluations.

• Prepare and track RAQA/PMS metrics and KPIs, identifying trends, backlogs, and areas for improvement.

• Facilitate the implementation of PMS process enhancements across RAQA.

⛳️ Requirements

• Bachelor’s degree in Engineering, Science, Regulatory Affairs, Quality Management, Business Administration, or a related field; equivalent relevant professional experience may be considered.

• At least 2 years of relevant experience in Regulatory Affairs, Quality Assurance, Post-Market Surveillance, Complaint Handling, or another regulated medical-device setting.

• Experience in a cross-functional and international matrix organization is preferred.

• Strong understanding of Post-Market Surveillance, Complaint Handling, Vigilance, Product Field Actions/FSCA, recalls, and Commercial Holds within the medical-device sector.

• Excellent project, time, and priority management skills.

• Strong analytical skills and sound judgment.

• Exceptional coordination and stakeholder management abilities.

• Capable of communicating regulatory and quality requirements to both internal and external stakeholders.

• Proficient in reviewing and interpreting product, complaint, distribution, and quality data.

• Able to engage with Competent Authorities and other key stakeholders effectively.

• High attention to detail, a process-oriented mindset, and strong documentation skills.

• Ability to identify process inefficiencies and contribute to continuous improvement and standardization efforts.

• Excellent interpersonal skills.

• Strong IT skills, including proficiency in Microsoft Office; experience with quality systems like TrackWise and reporting tools is a plus.

• Fluent in German and English; proficiency in additional languages is advantageous.

🏝️ Benefits

• Incentive compensation may be available, including bonuses and/or commissions where applicable.

• Comprehensive benefits package offered by Stryker.

• Flexibility in work arrangements, including remote, hybrid, or onsite options.