Senior Regulatory Affairs Specialist

As a Senior Regulatory Affairs Specialist, you will lead post-market surveillance activities for the GSA region across a broad range of Stryker products. You will collaborate with cross-functional teams to manage complaints, field actions, and holds, ensuring timely documentation and regulatory readiness. Your work supports continuous improvement of PMS processes and prepares the organization for inspections and audits. This role offers meaningful impact in maintaining compliance and advancing product safety across markets.

• remote or hybrid or onsite work
• comprehensive benefits package
• potential incentive compensation (bonus and/or commissions)
• competitive salary ranges
• transparent compensation discussions
• travel opportunities (up to 10%)

• Execute post-market surveillance activities focusing on complaint handling, PFAs/FSCA, commercial holds and related PMS tasks
• Coordinate intake, processing and closure of product complaints with proper documentation in quality systems
• Oversee local execution of product field actions, recalls, and commercial holds, including impact assessment and customer communications
• Review product scope, distribution and inventory, coordinating actions with stakeholders across regions and divisions
• Act as operational liaison between RAQA, PMS teams, Legal, Customer Service, Sales, Supply Chain and other stakeholders
• Escalate delays, gaps or compliance risks and ensure timely resolution
• Support communication with Competent Authorities and external stakeholders on PMS matters
• Maintain and monitor systems to track complaints, field actions, and PMS events
• Monitor cases, timelines and execution status to ensure procedures and timelines are met
• Support complaint trending and PMS metrics to identify trends and improvement opportunities
• Stay updated on applicable regulations and guidance influencing PMS activities
• Contribute to development and improvement of PMS procedures, SOPs, and training materials
• Prepare for regulatory inspections, audits and PMS assessments
• Provide guidance on PMS processes to internal stakeholders and promote awareness across functions
• Identify efficiencies and drive continuous improvement in PMS processes across RAQA
• Prepare regulatory correspondence and PMS documentation
• Demonstrate meticulous documentation and strong attention to detail
• Build cross-functional relationships and communicate regulatory requirements clearly
• Engage with authorities on routine and complex PMS matters with appropriate support
• Provide input for briefings and PMS documentation
• Support identification of process inefficiencies and standardization efforts
• Maintain strong IT proficiency and familiarity with quality systems like TrackWise

• 2+ years’ experience in Regulatory Affairs, Quality Assurance, Post-Market Surveillance or a regulated medical-device environment
• Strong understanding of Post-Market Surveillance, Complaint Handling, Vigilance, FSCA/ recalls and Commercial Holds in medical devices
• Ability to manage multiple PMS activities with good time and priority management
• Resilient in a fast-changing environment with urgent activities and competing deadlines
• Strong problem-solving skills and sound judgment with incomplete or changing information
• Proven ownership and ability to drive activities from initiation to completion with minimal supervision
• Excellent coordination and stakeholder-management across functions, countries and levels
• Clear, confident communication of regulatory and quality requirements
• Proactive follow-up and escalation of delays or ambiguous responsibilities
• Ability to create structure in complex situations with multiple stakeholders
• Ability to translate product, complaint and quality information into actionable tasks
• Effective communication with departments and authorities on PMS requirements
• Engagement with Competent Authorities and other stakeholders on routine/complex matters
• Support for briefings, regulatory correspondence and PMS documentation
• High attention to detail and strong documentation skills
• Ability to identify process inefficiencies and contribute to standardization
• Strong interpersonal skills for working in a matrix organization
• Strong IT skills including Microsoft Office; trackWise experience is advantageous
• Fluency in German and English; additional languages beneficial

• strong coordination and stakeholder-management
• excellent communication and collaboration
• problem-solving with sound judgment
• TrackWise
• Microsoft Office
• PMS and quality systems