SHQ Medtronic Int. Trading Sàrl
Regulatory Affairs Specialist(m/w/x)
Full-timeOn-siteExperienced
Lausanne
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MEMedtronic
Regulatory Affairs Specialist(m/w/x)
Lausanne
Full-timeOn-siteExperienced
Nejo AI Summary
Coordinating regulatory submissions for medical devices at global healthcare technology firm. 2-5 years medical device regulatory experience with Swissmedic submissions and trilingual proficiency (DE, EN, FR) essential. International regulatory environment, advanced tracking systems.
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
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
Work Experience
- 2 - 5 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
- French – Business Fluent
Benefits
Competitive Pay
- Competitive salary
Other Benefits
- Flexible benefits package
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Medtronic and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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MEMedtronic
Regulatory Affairs Specialist(m/w/x)
Lausanne
Full-timeOn-siteExperienced
Nejo AI Summary
Coordinating regulatory submissions for medical devices at global healthcare technology firm. 2-5 years medical device regulatory experience with Swissmedic submissions and trilingual proficiency (DE, EN, FR) essential. International regulatory environment, advanced tracking systems.
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
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
Work Experience
- 2 - 5 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
- French – Business Fluent
Benefits
Competitive Pay
- Competitive salary
Other Benefits
- Flexible benefits package
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Medtronic and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Medtronic
Industry
Healthcare
Description
The company leads global healthcare technology and aims to alleviate pain, restore health, and extend life.
Not a perfect match?
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