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Senior Staff Regulatory Affairs (m/f/d) at Stryker (Selzach, SO, Switzerland) | Careerkit Jobs
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Stryker
·
Medical Devices
·
Selzach, Solothurn
Senior Staff Regulatory Affairs (m/f/d)
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Role
Full-time · Permanent · Senior
Logistics
Hybrid
Compensation
CHF 108,500 - CHF 181,000 Annual
Requirements
5+ yrs exp · Bachelor's · EU/EFTA permit
How you match
01
See how well you match this job
See score →
Skills
02
Training
Communication
Mentoring
Design controls
Medical device development
Administrative process improvement
Quality management system
MDR 2017/745 compliance
SOP-Erstellung
FDA
Court submission management
IT Audit
Languages
English
German
Compensation
03
CHF 108,500 - CHF 181,000 Annual
The role
04
01
Lead regulatory strategy for new products and changes, ensuring global compliance
02
Prepare and manage submissions (e.g., FDA, EU MDR, post-market reports)
03
Act as a liaison with regulatory authorities and notified bodies
04
Review and approve labeling, marketing, and change documentation
05
Support audits and inspections, providing expert regulatory guidance
06
Monitor regulatory trends and communicate updates internally
07
Mentor junior RA team members and support training activities
08
Contribute to process improvements and SOP development
Requirements
↳
Bachelor-s degree in life sciences, engineering, or related field
↳
5+ years of experience in medical device Regulatory Affairs
↳
Strong knowledge of FDA, EU MDR, and global regulations
↳
Proven experience with Class II/III medical device submissions
↳
Excellent English communication skills
↳
Master-s degree or Regulatory Affairs Certification (RAC) (preferred)
↳
Experience in orthopedics or implantable devices (preferred)
↳
German language skills (preferred)
↳
Familiarity with Quality Systems and Design Control (preferred)
Benefits
＋
Flexible working hours model
＋
Opportunity to work partially from the home office
＋
Comprehensive benefits package
Company
05
Stryker
Medical Devices
Visit website ↗
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