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Regulatory Affairs Specialist(m/w/x)
Description
As a Regulatory Affairs Specialist, you will manage regulatory submissions and ensure compliance by recommending improvements and strategies. Your role involves coordinating with internal teams and staying updated on regulations while supporting decision-making processes.
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
- •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
- •Recommend improvements to enhance system and process effectiveness
- •Communicate regularly with internal stakeholders to share updates and gather input
- •Guide entry-level professionals or support staff as needed
Languages
German – Business Fluent
English – Business Fluent
French – Business Fluent
Benefits
Competitive Pay
- •Competitive salary
Other Benefits
- •Flexible benefits package
- SHQ Medtronic Int. Trading SàrlFull-timeOn-siteExperiencedLausanne
- SMO Medtronic Europe Sàrl
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Regulatory Affairs Specialist(m/w/x)
The AI Job Search Engine
Description
As a Regulatory Affairs Specialist, you will manage regulatory submissions and ensure compliance by recommending improvements and strategies. Your role involves coordinating with internal teams and staying updated on regulations while supporting decision-making processes.
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
- •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
- •Recommend improvements to enhance system and process effectiveness
- •Communicate regularly with internal stakeholders to share updates and gather input
- •Guide entry-level professionals or support staff as needed
Languages
German – Business Fluent
English – Business Fluent
French – Business Fluent
Benefits
Competitive Pay
- •Competitive salary
Other Benefits
- •Flexible benefits package
About the Company
Medtronic
Industry
Healthcare
Description
The company leads global healthcare technology and aims to alleviate pain, restore health, and extend life.
- SHQ Medtronic Int. Trading Sàrl
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