Regulatory Affairs Specialist — Stryker
NewCHF 68'500 - 104'000
Stryker · Biberist (SO)
- Location
- Biberist
- Contract
- full-time
- Posted
- Yesterday
SalaryCHF 68'500 - 104'000
Role overview
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.
- Work Flexibility: Hybrid
- Job Title: RAQA Specialist (m/f/d) – Regulatory Affairs & Quality Systems Job Summary:
Application process
- 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.
- · 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.
Company and context
- 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.
Additional details
- Job Title: RAQA Specialist (m/f/d) – Regulatory Affairs & Quality Systems
- Collaborating with cross-functional stakeholders and global teams, you will contribute to a compliant, efficient, and continuously improving RAQA organization.
- · Contribute to cross-functional projects and governance initiatives to strengthen RAQA processes and interfaces. What will you need
- · Proficiency in English and German, with strong communication and collaboration skills.
- · Confident stakeholder management skills and a continuous improvement mindset. Travel Percentage: 10%
Notes and original content
- Job Summary:
- What will you do
- · Contribute to cross-functional projects and governance initiatives to strengthen RAQA processes and interfaces.
- What will you need
- · Confident stakeholder management skills and a continuous improvement mindset.
- Travel Percentage: 10%
