Medtronic
Regulatory Affairs Specialist(m/w/x)
Full-timeOn-siteExperienced
Lausanne
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SHSHQ Medtronic Int. Trading Sàrl
Regulatory Affairs Specialist(m/w/x)
Lausanne
Full-timeOn-siteExperienced
Nejo AI Summary
Preparing and compiling regulatory submission packages for medical devices at firm developing solutions for challenging health problems. 2-5 years medical device regulatory experience with Swissmedic submissions and trilingual proficiency (DE, EN, FR) required. Work within ISO 13485 QMS environment.
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
- 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
Work Experience
- 2 - 5 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
- French – Basic
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 SHQ Medtronic Int. Trading Sàrl 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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SHSHQ Medtronic Int. Trading Sàrl
Regulatory Affairs Specialist(m/w/x)
Lausanne
Full-timeOn-siteExperienced
Nejo AI Summary
Preparing and compiling regulatory submission packages for medical devices at firm developing solutions for challenging health problems. 2-5 years medical device regulatory experience with Swissmedic submissions and trilingual proficiency (DE, EN, FR) required. Work within ISO 13485 QMS environment.
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
- 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
Work Experience
- 2 - 5 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
- French – Basic
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 SHQ Medtronic Int. Trading Sàrl 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
SHQ Medtronic Int. Trading Sàrl
Industry
Healthcare
Description
The company leads global healthcare technology and seeks solutions to challenging health problems.
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