Galderma SA
Paralegal – Contract Coordinator(m/w/x)
Full-timeInternshipWith Homeoffice
Lausanne
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HEHelen of Troy
Regulatory Affairs Coordinator(m/w/x)
Lausanne, Bussigny
Full-time, Part-timeWith Home OfficeJunior
Nejo AI Summary
Maintaining CE mark and compiling regulatory dossiers for consumer products in EMEA. 1-2 years regulatory affairs experience preferred. Flexible hours and work from home policy.
Requirements
- Fluent English and French
- University or Engineering degree in science or equivalent
- 1-2 years experience in regulatory affairs (preferred)
- MS Office proficiency
- Mandatory fluency in English
- Authorized to work in Switzerland
- Working knowledge of EN ISO 13485 or ISO 9001
- Working experience of CE marking and compliance
- Working experience of WEEE/REACH/RoHs/CLPs for Medical Device
- Knowledge of Low Voltage Directive / EMC Directive (asset)
Tasks
- Ensure regulatory documentation is current and compliant in EMEA
- Maintain CE mark
- Compile and submit regulatory dossiers
- Support timely approvals
- Support portfolio continuity
- Own Technical Documentation for assigned projects under MDR 2017/745
- Prepare change assessment files for Notified Body submissions
- Manage change assessment files for Notified Body submissions
- Lead MDR transition activities for legacy devices
- Collaborate cross-functionally with Product Development
- Collaborate cross-functionally with Marketing
- Collaborate cross-functionally with other teams
- Uphold product compliance
- Draft EU Declarations of Conformity and Compliance
- Maintain EU Declarations of Conformity and Compliance
- Review product labelling for regulatory accuracy
- Review marketing materials for regulatory accuracy
- Monitor Clinical Evaluation documentation
- Support Clinical Evaluation documentation
- Monitor Clinical Evaluation processes
- Support Clinical Evaluation processes
- Assist with product registration in Middle East, Africa, and APO
- Assist with product notification in Middle East, Africa, and APO
- Provide regulatory support aligned with sales demand
- Support assigned product categories
Work Experience
- 1 - 2 years
Education
- Bachelor's degree
Languages
- English – Native
- French – Business Fluent
Tools & Technologies
- MS Office
- EN ISO 13485
- ISO 9001
- CE marking
- WEEE
- REACH
- RoHs
- CLPs
- Low Voltage Directive
- EMC Directive
Benefits
Flexible Working
- Flexible working hours
- Work from home policy
Corporate Discounts
- Swibeco
- Employee discounts on EMEA products
Modern Office
- Modern office
- Collaborative workspaces
Mental Health Support
- Employee assistance counselling line
Free or Subsidized Food
- Lunch and Learns
More Vacation Days
- Company closure between Christmas and New Year’s
Informal Culture
- International, diverse, and inclusive environment
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Helen of Troy 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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HEHelen of Troy
Regulatory Affairs Coordinator(m/w/x)
Lausanne, Bussigny
Full-time, Part-timeWith Home OfficeJunior
Nejo AI Summary
Maintaining CE mark and compiling regulatory dossiers for consumer products in EMEA. 1-2 years regulatory affairs experience preferred. Flexible hours and work from home policy.
Requirements
- Fluent English and French
- University or Engineering degree in science or equivalent
- 1-2 years experience in regulatory affairs (preferred)
- MS Office proficiency
- Mandatory fluency in English
- Authorized to work in Switzerland
- Working knowledge of EN ISO 13485 or ISO 9001
- Working experience of CE marking and compliance
- Working experience of WEEE/REACH/RoHs/CLPs for Medical Device
- Knowledge of Low Voltage Directive / EMC Directive (asset)
Tasks
- Ensure regulatory documentation is current and compliant in EMEA
- Maintain CE mark
- Compile and submit regulatory dossiers
- Support timely approvals
- Support portfolio continuity
- Own Technical Documentation for assigned projects under MDR 2017/745
- Prepare change assessment files for Notified Body submissions
- Manage change assessment files for Notified Body submissions
- Lead MDR transition activities for legacy devices
- Collaborate cross-functionally with Product Development
- Collaborate cross-functionally with Marketing
- Collaborate cross-functionally with other teams
- Uphold product compliance
- Draft EU Declarations of Conformity and Compliance
- Maintain EU Declarations of Conformity and Compliance
- Review product labelling for regulatory accuracy
- Review marketing materials for regulatory accuracy
- Monitor Clinical Evaluation documentation
- Support Clinical Evaluation documentation
- Monitor Clinical Evaluation processes
- Support Clinical Evaluation processes
- Assist with product registration in Middle East, Africa, and APO
- Assist with product notification in Middle East, Africa, and APO
- Provide regulatory support aligned with sales demand
- Support assigned product categories
Work Experience
- 1 - 2 years
Education
- Bachelor's degree
Languages
- English – Native
- French – Business Fluent
Tools & Technologies
- MS Office
- EN ISO 13485
- ISO 9001
- CE marking
- WEEE
- REACH
- RoHs
- CLPs
- Low Voltage Directive
- EMC Directive
Benefits
Flexible Working
- Flexible working hours
- Work from home policy
Corporate Discounts
- Swibeco
- Employee discounts on EMEA products
Modern Office
- Modern office
- Collaborative workspaces
Mental Health Support
- Employee assistance counselling line
Free or Subsidized Food
- Lunch and Learns
More Vacation Days
- Company closure between Christmas and New Year’s
Informal Culture
- International, diverse, and inclusive environment
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Helen of Troy 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.
About the Company
Helen of Troy
Industry
Manufacturing
Description
The company is a prominent player in the global consumer products industry, offering diverse career opportunities and renowned brands.
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