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Program Manager/Senior Regulatory Affairs Specialist
Eingestellt von Quanta Consultancy Services
Gesuchte Skills: Design, Support
Projektbeschreibung
PROGRAM MANAGER/SENIOR REGULATORY AFFAIRS SPECIALIST
Our client, a top 20 medical device manufacturer, is currently undertaking a QA improvement drive for their Surgical Tools Division. They are looking for a Regulatory Affairs specialist to support them in resolving outstanding remediation items for their technical regulatory submission files. This position will lead large scope projects, of significant strategic importance to the business.
RESPONSIBILITIES
- Project Management
- Project objective: planning, development, leading and execution.
- Planning of all relevant activities that are necessary to achieve project target.
- Communication and coordination within the team.
- Planning and coordination of external service providers, eg laboratories, if needed.
- Periodic reporting to Steering Committees.
- Documentation of the project, such as project planning, reports, minutes, etc.
- Regulatory Affairs
- Make sure that the Technical File has proper and adequate structure and it links to all needed evidences.
- Support other functions (eg R&D, Manufacturing) to produce or remediate missing/incomplete evidences (Specification, Test Plans, Test reports, design transfer).
- Create and assure correct traceability (from Design input to Test cases to Design transfer).
- Review documents for compliance with Standard and Regulations, GDP, completeness and suitability of the technical contents and of the technical file for CE marking.
- Ensure the correct product configuration management.
- Advice on proper device classification and applicable standards and provide guidance.
- Supported by other functions ensure that risk management evidences are adequate and properly linked to Technical File.
REQUIREMENTS
- Excellent experience in RA for medical device (Class I and II).
- Strong experience in project management in international environment.
- Sound RA experience in MDD (including knowledge of Meddevs)
- Very good understanding and hands on experience on Design Control and Technical File for Class I and II medical device
- Knowledge of basic standards for medical electrical equipment (EN 60601-1, EN 60601-1-2, EN 60601-1-6, EN 62304, EN 62366). Good knowledge of ISO 13485.
- Full working knowledge of and significant level of experience with product development including project management including all relevant cross-departments.
- Ability to develop large scale project schedules, and to assess and manage cross functional team's progress on assignments relative to project schedule.
- Professional, concise, tactful and sensitive in communications. Able to diplomatically negotiate with internal or external customers.
- Demonstrated good written and verbal communication skills including presentation skills.
Our client, a top 20 medical device manufacturer, is currently undertaking a QA improvement drive for their Surgical Tools Division. They are looking for a Regulatory Affairs specialist to support them in resolving outstanding remediation items for their technical regulatory submission files. This position will lead large scope projects, of significant strategic importance to the business.
RESPONSIBILITIES
- Project Management
- Project objective: planning, development, leading and execution.
- Planning of all relevant activities that are necessary to achieve project target.
- Communication and coordination within the team.
- Planning and coordination of external service providers, eg laboratories, if needed.
- Periodic reporting to Steering Committees.
- Documentation of the project, such as project planning, reports, minutes, etc.
- Regulatory Affairs
- Make sure that the Technical File has proper and adequate structure and it links to all needed evidences.
- Support other functions (eg R&D, Manufacturing) to produce or remediate missing/incomplete evidences (Specification, Test Plans, Test reports, design transfer).
- Create and assure correct traceability (from Design input to Test cases to Design transfer).
- Review documents for compliance with Standard and Regulations, GDP, completeness and suitability of the technical contents and of the technical file for CE marking.
- Ensure the correct product configuration management.
- Advice on proper device classification and applicable standards and provide guidance.
- Supported by other functions ensure that risk management evidences are adequate and properly linked to Technical File.
REQUIREMENTS
- Excellent experience in RA for medical device (Class I and II).
- Strong experience in project management in international environment.
- Sound RA experience in MDD (including knowledge of Meddevs)
- Very good understanding and hands on experience on Design Control and Technical File for Class I and II medical device
- Knowledge of basic standards for medical electrical equipment (EN 60601-1, EN 60601-1-2, EN 60601-1-6, EN 62304, EN 62366). Good knowledge of ISO 13485.
- Full working knowledge of and significant level of experience with product development including project management including all relevant cross-departments.
- Ability to develop large scale project schedules, and to assess and manage cross functional team's progress on assignments relative to project schedule.
- Professional, concise, tactful and sensitive in communications. Able to diplomatically negotiate with internal or external customers.
- Demonstrated good written and verbal communication skills including presentation skills.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Sonstiges