Heumann Pharma GmbH & Co. Generica KG
Manager Regulatory Affairs(m/w/x)
Full-timeOn-siteExperienced
Nürnberg
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ALAlcon
Regulatory Affairs Strategy Sr. Associate(m/w/x)
Erlangen
Full-timeOn-siteSenior
Nejo AI Summary
Global medical device submissions and product approval support. 5+ years of hands-on regulatory affairs experience required. 6 weeks vacation, company car for private use.
Requirements
- Degree in Life Sciences, Biomedical Engineering, Pharmacy, or related field
- English and German fluency (written and verbal)
- 5+ years of experience with global medical device submissions
- Strong motivation to expand regulatory expertise
- Hands-on Regulatory Affairs experience
- Ready to take ownership of market submissions
- Cross-functional regulatory coordination experience
- Ability to work with technical documentation
- Ability to work with regulatory submissions
- Ability to work with compliance-related materials
- Strong attention to detail
- Solid communication skills
- Effective collaboration with cross-functional teams
- Professional interaction with regulatory agencies
- Strong organizational abilities
- Strong time-management abilities
- Support multiple tasks, submissions, and deadlines
- Work in a structured environment
- Commitment to quality
- Adherence to GxP
- Adherence to SOPs
- Accurate documentation practices
- Continuous learning through required trainings
Tasks
- Contribute to regulatory strategy development
- Support activities for product approvals
- Ensure alignment with global and local requirements
- Prepare regulatory submissions
- Coordinate regulatory submissions
- Collaborate with internal teams on submissions
- Work with manufacturing sites on submissions
- Liaise with regulatory agents on submissions
- Engage with health authorities on submissions
- Review promotional materials for compliance
- Review labeling for compliance
- Maintain technical documentation
- Maintain dossiers
- Support product lifecycle activities
- Assess regulatory impacts of changes
- Assist with regulatory pathways for modifications
- Ensure continuous compliance across the portfolio
- Facilitate cross-functional interactions
- Facilitate authority interactions
- Provide regulatory input
- Address country-specific queries
- Serve as a key communication point
- Maintain strict compliance with GxP
- Maintain compliance with quality systems
- Follow SOPs
- Keep thorough documentation
- Complete required training
- Contribute to audits
- Contribute to inspections
- Contribute to process improvements
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- EU MDR technical Documentation
- FDA 510(k)/PMAs
- Health Canada Class II & III
- ISO
Benefits
Other Benefits
- Product lifecycle management
- Supportive workplace
- Global leader
- Medical technology
Informal Culture
- Team collaboration
Startup Environment
- Dynamic workplace
Purpose-Driven Work
- Life-changing advancements
Ergonomic Workplace
- Eye care
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Alcon 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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Regulatory Affairs Strategy Sr. Associate(m/w/x)
Erlangen
Full-timeOn-siteSenior
Nejo AI Summary
Global medical device submissions and product approval support. 5+ years of hands-on regulatory affairs experience required. 6 weeks vacation, company car for private use.
Requirements
- Degree in Life Sciences, Biomedical Engineering, Pharmacy, or related field
- English and German fluency (written and verbal)
- 5+ years of experience with global medical device submissions
- Strong motivation to expand regulatory expertise
- Hands-on Regulatory Affairs experience
- Ready to take ownership of market submissions
- Cross-functional regulatory coordination experience
- Ability to work with technical documentation
- Ability to work with regulatory submissions
- Ability to work with compliance-related materials
- Strong attention to detail
- Solid communication skills
- Effective collaboration with cross-functional teams
- Professional interaction with regulatory agencies
- Strong organizational abilities
- Strong time-management abilities
- Support multiple tasks, submissions, and deadlines
- Work in a structured environment
- Commitment to quality
- Adherence to GxP
- Adherence to SOPs
- Accurate documentation practices
- Continuous learning through required trainings
Tasks
- Contribute to regulatory strategy development
- Support activities for product approvals
- Ensure alignment with global and local requirements
- Prepare regulatory submissions
- Coordinate regulatory submissions
- Collaborate with internal teams on submissions
- Work with manufacturing sites on submissions
- Liaise with regulatory agents on submissions
- Engage with health authorities on submissions
- Review promotional materials for compliance
- Review labeling for compliance
- Maintain technical documentation
- Maintain dossiers
- Support product lifecycle activities
- Assess regulatory impacts of changes
- Assist with regulatory pathways for modifications
- Ensure continuous compliance across the portfolio
- Facilitate cross-functional interactions
- Facilitate authority interactions
- Provide regulatory input
- Address country-specific queries
- Serve as a key communication point
- Maintain strict compliance with GxP
- Maintain compliance with quality systems
- Follow SOPs
- Keep thorough documentation
- Complete required training
- Contribute to audits
- Contribute to inspections
- Contribute to process improvements
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- EU MDR technical Documentation
- FDA 510(k)/PMAs
- Health Canada Class II & III
- ISO
Benefits
Other Benefits
- Product lifecycle management
- Supportive workplace
- Global leader
- Medical technology
Informal Culture
- Team collaboration
Startup Environment
- Dynamic workplace
Purpose-Driven Work
- Life-changing advancements
Ergonomic Workplace
- Eye care
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Alcon 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
Alcon
Industry
Healthcare
Description
The company is a global leader in eye care, dedicated to helping people see brilliantly through innovative solutions.
Not a perfect match?
- Heumann Pharma GmbH & Co. Generica KG
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Full-timeOn-siteExperiencedErlangen