Work Flexibility: Hybrid Job Title: RAQA Specialist (m/f/d) – Regulatory Affairs & Quality Systems
Job Summary
As a RAQA Specialist, you will support Regulatory Affairs and Quality activities for our business across Germany, Switzerland, and Austria (GSA), with a strong focus on Swiss registration requirements. You will help ensure compliance with MDR 2017/745 and applicable Swiss legislation (e.g., MedDO), drive product registration and maintenance activities (including Swissmedic/Swiss regulatory applications such as Swissdamed), and support continuous improvement of Quality Management System (QMS) processes. Collaborating with cross-functional stakeholders and global teams, you will contribute to a compliant, efficient, and continuously improving RAQA organization. What will you do · Support product registration and lifecycle maintenance activities for Switzerland (and GSA as applicable), including preparation, review, and maintenance of regulatory documentation and registrations. · Coordinate and support Swiss regulatory submissions/notifications and system activities (e.g., Swissdamed and related Swissmedic applications), ensuring data quality, completeness, and compliance. · Support the monitoring of regulatory requirements (MDR and Swiss MedDO) and support impact assessments and implementation of changes. · Provide day-to-day RAQA process support to internal stakeholders (e.g., Supply Chain, Customer Service, Technical Service, Commercial), including guidance on local regulatory requirements. · Support QMS processes and documentation (e.g., SOP updates, records management, training support) and contribute to continuous improvement initiatives. · Support internal and external audits and inspection readiness activities related to RA/QA topics. · Contribute to cross-functional projects and governance initiatives to strengthen RAQA processes and interfaces. What will you need Required · Bachelor's degree in Engineering, Science, or a related field. Master’s is a plus. · 2+ years of experience in Regulatory Affairs & Quality Assurance (RAQA) or a related role in a medical device, pharmaceutical, or other highly regulated industry. · Practical experience in one or more of the following areas is preferred: regulatory submissions/registrations, product registration maintenance, QMS process support, change control documentation, or regulatory compliance activities. · Proficiency in English and German, with strong communication and collaboration skills. Preferred · Knowledge of MDR 2017/745 and Swiss medical device legislation (e.g., MedDO), and an understanding of Swiss market requirements (e.g., CH-REP/Swiss registration concepts). ·
Experience
with Swiss regulatory tools/systems (e.g., Swissdamed) or comparable registration databases and data maintenance activities. ·
Experience
supporting QMS documentation processes (e.g., SOP changes, training deployment, audit support). · Confident stakeholder management skills and a continuous improvement mindset. Travel Percentage: 10% Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.