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Regulatory Affairs Specialist (m/f)
Eingestellt von Michael Bailey Associates - Munich
Projektbeschreibung
REGULATORY AFFAIRS SPECIALIST (M/F)
JOB DESCRIPTION:
Drawing on relevant expertise and information from both internal and external sources, make a major contribution towards the preparation of any critical regulatory documentation
Responsibilities
Ensuring that the company's products comply with the regulations of government agencies
Keeping abreast of international legislation, guidelines and customer practices.
Collecting and collating a wide range of information
Keeping up to date with a company's product range
Developing and writing clear arguments and explanations for new product licenses and license renewals life cycle Management -Update of technical documentation
Understanding and evaluating complex information
Working with specialist computer software and resources
Writing clear, accessible product labels and patient information leaflets
Advising scientists and manufacturers on regulatory requirements
Resolving complex issues as they arise
Preparing and coordinating documentation
Project managing teams of colleagues involved with the development of new products or life cycle Management activities
Maintaining quality systems.
REQUIREMENTS:
Proven expertise of Medical Device Regulatory Affairs
Business development skill sets with exposure to or having worked in a regulatory consultancy model
Be able to demonstrate driving partnerships within the industry
Excellent attention to detail
Degree or equivalent in a Life Science
Excellent communicator, both verbal and written
More than excellent command of English
English and German spoken and written.
OTHERS
Work location: Waldenburg/Basel-Country
Start date: ASAP
End date: 31/12/14 (extension possible)Michael Bailey International is acting as an Employment Business in relation to this vacancy.
JOB DESCRIPTION:
Drawing on relevant expertise and information from both internal and external sources, make a major contribution towards the preparation of any critical regulatory documentation
Responsibilities
Ensuring that the company's products comply with the regulations of government agencies
Keeping abreast of international legislation, guidelines and customer practices.
Collecting and collating a wide range of information
Keeping up to date with a company's product range
Developing and writing clear arguments and explanations for new product licenses and license renewals life cycle Management -Update of technical documentation
Understanding and evaluating complex information
Working with specialist computer software and resources
Writing clear, accessible product labels and patient information leaflets
Advising scientists and manufacturers on regulatory requirements
Resolving complex issues as they arise
Preparing and coordinating documentation
Project managing teams of colleagues involved with the development of new products or life cycle Management activities
Maintaining quality systems.
REQUIREMENTS:
Proven expertise of Medical Device Regulatory Affairs
Business development skill sets with exposure to or having worked in a regulatory consultancy model
Be able to demonstrate driving partnerships within the industry
Excellent attention to detail
Degree or equivalent in a Life Science
Excellent communicator, both verbal and written
More than excellent command of English
English and German spoken and written.
OTHERS
Work location: Waldenburg/Basel-Country
Start date: ASAP
End date: 31/12/14 (extension possible)Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Sonstiges