Alstom
Indirect Buyer(m/w/x)
Full-timeOn-siteExperienced
Bautzen
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ONOntex Group NV
Group Regulatory Affairs Specialist Class II(m/w/x)
Großpostwitz/O.L.
Full-timeOn-siteExperienced
Nejo AI Summary
Regulatory research for medical devices in personal hygiene solutions, monitoring global environment for international provider. In-depth US/Canada medical device regulations knowledge essential. Holiday/Christmas bonuses, 30 days vacation.
Requirements
- Master’s degree in science or equivalent experience
- In-depth knowledge of US and Canada regulations for medical devices
- Knowledge of medical device regulations in Central America, South America (Brazil)
- Knowledge of quality management systems and medical device standards such as ISO 13485, ISO 14971
- Certifications in regulatory affairs like RAC
- Fluency in English and any other language
- Minimum of 3 years experience in Regulatory Affairs for medical devices
- Experience in 510k submission
- Experience or interest in regulatory affairs for Software as Medical Device (SAMD)
- Experience in working with cross-functional teams
- Ability to integrate and demonstrate core values, integrity and accountability
- Ability to lead, manage, collaborate and communicate within the organization
Tasks
- Research regulatory requirements for submissions and compliance
- Monitor the regulatory environment and provide innovative advice
- Supervise data input activities and analyze impact reports
- Identify needs for new regulatory procedures and develop SOPs
- Assess market access requirements and potential obstacles
- Evaluate preclinical, clinical, and manufacturing documents
- Provide regulatory input on global requirements to product teams
- Advise stakeholders on regulatory requirements for quality data
- Collaborate with cross-functional teams on regulatory interactions
- Communicate with regulatory authorities during submissions
- Submit relevant reports to regulatory authorities during research
- Notify authorities about product safety issues for compliance
- Support inspections and audits with regulatory input
- Submit changes and updates to regulatory authorities
- Ensure post-market regulatory requirements are met
- Improve quality of policies and services provided
- Maintain knowledge of evolving regulatory information systems
- Assist in developing and monitoring departmental budgets
- Identify vital resources for project teams
- Track scientific advances impacting product development
- Participate in education and studies to meet regulatory needs
- Engage in stakeholder groups for science-based decision-making
Work Experience
- 3 years
Education
- Master's degree
Languages
- English – Business Fluent
Benefits
Bonuses & Incentives
- Holiday and Christmas bonuses
More Vacation Days
- 30 days of holiday
Retirement Plans
- Company pension scheme
Corporate Discounts
- Corporate benefits and discounts
Diverse Work
- Exciting and varied working environment
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Ontex Group NV 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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ONOntex Group NV
Group Regulatory Affairs Specialist Class II(m/w/x)
Großpostwitz/O.L.
Full-timeOn-siteExperienced
Nejo AI Summary
Regulatory research for medical devices in personal hygiene solutions, monitoring global environment for international provider. In-depth US/Canada medical device regulations knowledge essential. Holiday/Christmas bonuses, 30 days vacation.
Requirements
- Master’s degree in science or equivalent experience
- In-depth knowledge of US and Canada regulations for medical devices
- Knowledge of medical device regulations in Central America, South America (Brazil)
- Knowledge of quality management systems and medical device standards such as ISO 13485, ISO 14971
- Certifications in regulatory affairs like RAC
- Fluency in English and any other language
- Minimum of 3 years experience in Regulatory Affairs for medical devices
- Experience in 510k submission
- Experience or interest in regulatory affairs for Software as Medical Device (SAMD)
- Experience in working with cross-functional teams
- Ability to integrate and demonstrate core values, integrity and accountability
- Ability to lead, manage, collaborate and communicate within the organization
Tasks
- Research regulatory requirements for submissions and compliance
- Monitor the regulatory environment and provide innovative advice
- Supervise data input activities and analyze impact reports
- Identify needs for new regulatory procedures and develop SOPs
- Assess market access requirements and potential obstacles
- Evaluate preclinical, clinical, and manufacturing documents
- Provide regulatory input on global requirements to product teams
- Advise stakeholders on regulatory requirements for quality data
- Collaborate with cross-functional teams on regulatory interactions
- Communicate with regulatory authorities during submissions
- Submit relevant reports to regulatory authorities during research
- Notify authorities about product safety issues for compliance
- Support inspections and audits with regulatory input
- Submit changes and updates to regulatory authorities
- Ensure post-market regulatory requirements are met
- Improve quality of policies and services provided
- Maintain knowledge of evolving regulatory information systems
- Assist in developing and monitoring departmental budgets
- Identify vital resources for project teams
- Track scientific advances impacting product development
- Participate in education and studies to meet regulatory needs
- Engage in stakeholder groups for science-based decision-making
Work Experience
- 3 years
Education
- Master's degree
Languages
- English – Business Fluent
Benefits
Bonuses & Incentives
- Holiday and Christmas bonuses
More Vacation Days
- 30 days of holiday
Retirement Plans
- Company pension scheme
Corporate Discounts
- Corporate benefits and discounts
Diverse Work
- Exciting and varied working environment
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Ontex Group NV 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
Ontex Group NV
Industry
Healthcare
Description
The company is a leading international provider of personal hygiene solutions for retailer brands and healthcare partners.
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