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Regulatory Affairs Specialist
Eingestellt von Harvey Nash IT Recruitment Switzerland
Gesuchte Skills: Network, Sap
Projektbeschreibung
Job: Regulatory Affairs Specialist/JNJKJP
Work location: Oberdorf, Baselland
Start date: 18.04.2017
End date: 31.12.2017
Technical File Remediation:
* Drawing on relevant expertise and information from internal and external sources, make a major contribution towards the preparation of regulatory documentation (eg Technical Files).
Responsibilities:
* Support the internal Regulatory Affairs group in creation and maintenance of Technical File documentation
* Reviewing of Risk Management Documentation according to EN ISO 14971:2012 with respect to regulatory regulatory requirements.
* Reviewing of labelling and promotion material for accuracy and consistency.
* Ensuring that the company's products comply with the regulations of government agencies, including but not limited to:
-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 regulatory documentation
-Advising scientists and manufacturers on regulatory requirements.
-Reviewing change requests
-Reviewing, preparing and coordinating documentation.
-Reviewing company practices and providing advice on changes to systems.
Requirements:
- Prior Synthes experience preferable (working knowledge of Windchill, Agile, SAP etc.)
. Expertise of Regulatory Affairs, including:
. Profound knowledge of European Medical Device Regulations, especially Council Directive 93/42/EEC
. Experience with Risk Management documentation for medical devices according to EN ISO 14971:2012
. 2-3 years of experience in Medical device Regulatory
. Familiarity with Technical Documentation structure according to STED
. Technically versed in computer software such as MS Word, Excel, Powerpoint, Strong database skills (Access) desired.
. Strong analytical skills and network thinking
. Be able to demonstrate driving partnerships within the industry.
. Proven ability of interpreting legislation and impact to meet commercial needs.
. Proven capability of successful working relationships with regulatory bodies.
. Demonstrate an appreciation and understanding of the positive impact of regulatory in delivering business solutions. Excellent communication and interpersonal skills, ability to influence.
. Proven success at managing and driving a team to meet strategic goals and KPIs
. Excellent attention to detail.
. Degree or equivalent in a Life Science.
. Excellent communicator, both verbal and written.
. Excellent command of English and German.
Work location: Oberdorf, Baselland
Start date: 18.04.2017
End date: 31.12.2017
Technical File Remediation:
* Drawing on relevant expertise and information from internal and external sources, make a major contribution towards the preparation of regulatory documentation (eg Technical Files).
Responsibilities:
* Support the internal Regulatory Affairs group in creation and maintenance of Technical File documentation
* Reviewing of Risk Management Documentation according to EN ISO 14971:2012 with respect to regulatory regulatory requirements.
* Reviewing of labelling and promotion material for accuracy and consistency.
* Ensuring that the company's products comply with the regulations of government agencies, including but not limited to:
-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 regulatory documentation
-Advising scientists and manufacturers on regulatory requirements.
-Reviewing change requests
-Reviewing, preparing and coordinating documentation.
-Reviewing company practices and providing advice on changes to systems.
Requirements:
- Prior Synthes experience preferable (working knowledge of Windchill, Agile, SAP etc.)
. Expertise of Regulatory Affairs, including:
. Profound knowledge of European Medical Device Regulations, especially Council Directive 93/42/EEC
. Experience with Risk Management documentation for medical devices according to EN ISO 14971:2012
. 2-3 years of experience in Medical device Regulatory
. Familiarity with Technical Documentation structure according to STED
. Technically versed in computer software such as MS Word, Excel, Powerpoint, Strong database skills (Access) desired.
. Strong analytical skills and network thinking
. Be able to demonstrate driving partnerships within the industry.
. Proven ability of interpreting legislation and impact to meet commercial needs.
. Proven capability of successful working relationships with regulatory bodies.
. Demonstrate an appreciation and understanding of the positive impact of regulatory in delivering business solutions. Excellent communication and interpersonal skills, ability to influence.
. Proven success at managing and driving a team to meet strategic goals and KPIs
. Excellent attention to detail.
. Degree or equivalent in a Life Science.
. Excellent communicator, both verbal and written.
. Excellent command of English and German.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, SAP Entwicklung