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Regulatory Affairs Specialist
Eingestellt von Next Ventures Ltd
Gesuchte Skills: Design, Support
Projektbeschreibung
For one of our longstanding clients based in Switzerland, Next Ventures is urgently seeking an experienced Regulatory Affairs Specialist for a long term contract.
SCOPE OF WORK
Assist in the creation of technical documentation (technical files and design dossiers for the business that will meet the requirements of the new Medical Device Regulation (MDR) in the European Union.
RESPONSIBILITIES
Identify reference documents for technical documentation including, but not limited to design and risk documents, verification/validation documents, standards conformance, and labeling.
Identify and adhere to policies, procedures and work instructions which support technical documentation activities.
Provide support for Clinical Evaluation Reports including references to required documentation.
Align technical documentation according to technical documentation structure proposed by the team.
Prepare technical documentation for submission to and review by Notified Bodies, as required.
EXPERIENCE
Strong working knowledge of EU Medical Device Regulations and guidance documents as well as relevant standards.
Ability to work with cross-functional team members including (but not limited to) R&D, Quality, Labeling, Sterility, Medical and Clinical.
Experience in working with PLM systems (ie Agile and Windchill).
Strong proficiency in Microsoft Office including Word and Excel.
Excellent written and oral communication skills.
Languages: English required, German a plus.
Ability to manage multiple tasks and be detail-oriented.
RAC CERTIFICATION IS A STRONG PREFERENCE
If you are available within the next 4 weeks and interested to apply, please submit your CV to (see below) for immediate consideration.
SCOPE OF WORK
Assist in the creation of technical documentation (technical files and design dossiers for the business that will meet the requirements of the new Medical Device Regulation (MDR) in the European Union.
RESPONSIBILITIES
Identify reference documents for technical documentation including, but not limited to design and risk documents, verification/validation documents, standards conformance, and labeling.
Identify and adhere to policies, procedures and work instructions which support technical documentation activities.
Provide support for Clinical Evaluation Reports including references to required documentation.
Align technical documentation according to technical documentation structure proposed by the team.
Prepare technical documentation for submission to and review by Notified Bodies, as required.
EXPERIENCE
Strong working knowledge of EU Medical Device Regulations and guidance documents as well as relevant standards.
Ability to work with cross-functional team members including (but not limited to) R&D, Quality, Labeling, Sterility, Medical and Clinical.
Experience in working with PLM systems (ie Agile and Windchill).
Strong proficiency in Microsoft Office including Word and Excel.
Excellent written and oral communication skills.
Languages: English required, German a plus.
Ability to manage multiple tasks and be detail-oriented.
RAC CERTIFICATION IS A STRONG PREFERENCE
If you are available within the next 4 weeks and interested to apply, please submit your CV to (see below) for immediate consideration.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Sonstiges