Post by sidali on Sept 16, 2015 17:25:07 GMT
TOPCON search Manager, Regulatory Labelling
Location: Netherland
POSITION Manager, TOPCON Regulatory Labelling
SUPERVISOR Associate Director, Regulatory Labelling Strategy and Operations
DEPARTMENT Regulatory Affairs
Contact: sidali.melbouci@topcon.com
General Activities:
• Lead the preparation, maintenance, and finalisation of labelling texts for internal review before submission to regulatory authorities.
• Lead the provision of labelling Annexes to Regulatory Affairs during product development to ensure ongoing alignment with clinical, regulatory and commercial strategies.
• Ensure compliance with current EU regulations, guidances and templates. Have confident ability to discuss these guidances in project meetings.
• Act as EU Regulatory Labelling guidance and answer any technical or procedural queries relating to them
• Versions, archives and distributes final dossier for internal use;
Responsibilities will include, but are not limited to, the following:
• Responsible for review and compilation of change control workflows for updates to labelling text and artwork for multiple products marketed
• Manage electronic archiving of draft mock-ups and label texts, and packaging artwork, including version control and archiving
• Manage the development and maintenance of the core abbreviated product information documents
• Deputise for Associate Director, Regulatory Labelling in her absence.
Competencies and Behaviours:
• Monitor compliance with labelling , working practices;
• Detailed understanding of global medical device development .
• Detailed understanding, regulatory submissions, and approval processes, including labelling requirements throughout the product lifecycle.
• Escalate issues and concerns to team leader;
• Expected to proactively ask questions to clarify understanding;
• Build knowledge by supporting the team in analysing and processing labelling components;
• Being driven by a constant eye for quality and attention to detail
• Prepared to answer questions during authority inspections and during internal audits on processes
• Confident with data input for document management systems.
• Ability to prioritise workload and handle multiple projects.
• Excellent writing, editing and proofreading skills with attention to detail.
• Demonstrated ability to interact effectively with cross-functional teams and regulatory agencies.
• Scientific background desirable.
Previous experience:
• Experience in quality control of documents
• Experience of working on large and demanding translation project.
If you have not received a response within 5 working days of forwarding your CV to us, then unfortunately you have been unsuccessful on this occasion.
Location: Netherland
POSITION Manager, TOPCON Regulatory Labelling
SUPERVISOR Associate Director, Regulatory Labelling Strategy and Operations
DEPARTMENT Regulatory Affairs
Contact: sidali.melbouci@topcon.com
General Activities:
• Lead the preparation, maintenance, and finalisation of labelling texts for internal review before submission to regulatory authorities.
• Lead the provision of labelling Annexes to Regulatory Affairs during product development to ensure ongoing alignment with clinical, regulatory and commercial strategies.
• Ensure compliance with current EU regulations, guidances and templates. Have confident ability to discuss these guidances in project meetings.
• Act as EU Regulatory Labelling guidance and answer any technical or procedural queries relating to them
• Versions, archives and distributes final dossier for internal use;
Responsibilities will include, but are not limited to, the following:
• Responsible for review and compilation of change control workflows for updates to labelling text and artwork for multiple products marketed
• Manage electronic archiving of draft mock-ups and label texts, and packaging artwork, including version control and archiving
• Manage the development and maintenance of the core abbreviated product information documents
• Deputise for Associate Director, Regulatory Labelling in her absence.
Competencies and Behaviours:
• Monitor compliance with labelling , working practices;
• Detailed understanding of global medical device development .
• Detailed understanding, regulatory submissions, and approval processes, including labelling requirements throughout the product lifecycle.
• Escalate issues and concerns to team leader;
• Expected to proactively ask questions to clarify understanding;
• Build knowledge by supporting the team in analysing and processing labelling components;
• Being driven by a constant eye for quality and attention to detail
• Prepared to answer questions during authority inspections and during internal audits on processes
• Confident with data input for document management systems.
• Ability to prioritise workload and handle multiple projects.
• Excellent writing, editing and proofreading skills with attention to detail.
• Demonstrated ability to interact effectively with cross-functional teams and regulatory agencies.
• Scientific background desirable.
Previous experience:
• Experience in quality control of documents
• Experience of working on large and demanding translation project.
If you have not received a response within 5 working days of forwarding your CV to us, then unfortunately you have been unsuccessful on this occasion.