The AI Job Search Engine
Group Regulatory Affairs Specialist Class II(m/w/x)
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
Not a perfect match?
- AlstomFull-timeOn-siteExperiencedBautzen
- Palfinger Platforms GmbH
Production Manager(m/w/x)
Full-timeOn-siteExperiencedLöbau - IQVIA CSMS GmbH
Pharmaberater Immunologie(m/w/x)
Full-timeOn-siteExperiencedGörlitz, Bautzen, Hoyerswerda, Zittau, Löbau, Rothenburg/Oberlausitz - Segula Technologies
Mitarbeiter, Lager Leitstand(m/w/x)
Full-timeOn-siteExperiencedBautzen - PALFINGER
HSE Manager(m/w/x)
Full-timeOn-siteManagementLöbau
Group Regulatory Affairs Specialist Class II(m/w/x)
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
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.
Not a perfect match?
- Alstom
Indirect Buyer(m/w/x)
Full-timeOn-siteExperiencedBautzen - Palfinger Platforms GmbH
Production Manager(m/w/x)
Full-timeOn-siteExperiencedLöbau - IQVIA CSMS GmbH
Pharmaberater Immunologie(m/w/x)
Full-timeOn-siteExperiencedGörlitz, Bautzen, Hoyerswerda, Zittau, Löbau, Rothenburg/Oberlausitz - Segula Technologies
Mitarbeiter, Lager Leitstand(m/w/x)
Full-timeOn-siteExperiencedBautzen - PALFINGER
HSE Manager(m/w/x)
Full-timeOn-siteManagementLöbau