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Regulatory Affairs Specialist(m/w/x)
Description
In this role, you will enhance regulatory processes and systems while collaborating with internal teams. Your day-to-day responsibilities will involve preparing submissions, guiding junior staff, and ensuring compliance with evolving regulations.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
Requirements
- •Bachelor's degree in Life Sciences, Engineering, Chemistry, or related technical field
- •2-5 years of medical device regulatory experience tied to Swissmedic submissions and processes
- •Proficiency in German, English, and French
- •Experience in ISO 13485 Quality Management Systems and risk management (ISO 14971, EN 14971)
- •Experience with Swissmedic registration processes and technical documentation preparation
Education
Work Experience
2 - 5 years
Tasks
- •Recommend improvements to systems and processes
- •Communicate regularly with internal stakeholders
- •Guide entry-level professionals and support staff
- •Coordinate and prepare document packages for regulatory submissions
- •Lead and compile materials for submissions, license renewals, and annual registrations
- •Recommend changes for labeling, manufacturing, marketing, and clinical protocols
- •Monitor and improve tracking and control systems
- •Stay updated on regulatory procedures and changes
- •Interact with regulatory agencies on defined matters
- •Suggest strategies for timely approvals of clinical trial applications
Languages
German – Business Fluent
English – Business Fluent
French – Basic
Benefits
Competitive Pay
- •Competitive salary
Other Benefits
- •Flexible benefits package
- MedtronicFull-timeOn-siteExperiencedLausanne
- SMO Medtronic Europe Sàrl
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Regulatory Affairs Specialist(m/w/x)
The AI Job Search Engine
Description
In this role, you will enhance regulatory processes and systems while collaborating with internal teams. Your day-to-day responsibilities will involve preparing submissions, guiding junior staff, and ensuring compliance with evolving regulations.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
Requirements
- •Bachelor's degree in Life Sciences, Engineering, Chemistry, or related technical field
- •2-5 years of medical device regulatory experience tied to Swissmedic submissions and processes
- •Proficiency in German, English, and French
- •Experience in ISO 13485 Quality Management Systems and risk management (ISO 14971, EN 14971)
- •Experience with Swissmedic registration processes and technical documentation preparation
Education
Work Experience
2 - 5 years
Tasks
- •Recommend improvements to systems and processes
- •Communicate regularly with internal stakeholders
- •Guide entry-level professionals and support staff
- •Coordinate and prepare document packages for regulatory submissions
- •Lead and compile materials for submissions, license renewals, and annual registrations
- •Recommend changes for labeling, manufacturing, marketing, and clinical protocols
- •Monitor and improve tracking and control systems
- •Stay updated on regulatory procedures and changes
- •Interact with regulatory agencies on defined matters
- •Suggest strategies for timely approvals of clinical trial applications
Languages
German – Business Fluent
English – Business Fluent
French – Basic
Benefits
Competitive Pay
- •Competitive salary
Other Benefits
- •Flexible benefits package
About the Company
SHQ Medtronic Int. Trading Sàrl
Industry
Healthcare
Description
The company leads global healthcare technology and seeks solutions to challenging health problems.
- Medtronic
Regulatory Affairs Specialist(m/w/x)
Full-timeOn-siteExperiencedLausanne - SMO Medtronic Europe Sàrl
Quality Systems Specialist(m/w/x)
Full-timeOn-siteExperiencedfrom CHF 144,000 / yearTolochenaz, Lausanne - SMO Medtronic Europe Sàrl
Quality Systems Specialist(m/w/x)
Full-timeOn-siteExperiencedfrom CHF 144,000 / yearLausanne - SICPA SA
HR Operations Specialist(m/w/x)
Full-timeOn-siteSeniorPrilly - IMD - International Institute
Information Security & Compliance Lead(m/w/x)
Full-timeOn-siteSeniorLausanne