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Regulatory Affairs Specialist
Eingestellt von Gazelle Global Consulting
Gesuchte Skills: Design, Support
Projektbeschreibung
REGULATORY AFFAIRS SPECIALIST
One of my Clinical Clients is urgently looking for a Regulatory Affairs Specialist for a 6-12 month contract in Bern, Switzerland. assist in the creation of technical documentation (technical files and design dossiers) for the DePuy Synthes TCMFB 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 labelling.
- 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 OneMD technical documentation structure proposed by the MDR 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, Labelling, 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 SPEAKING REQUIRED, GERMAN SPEAKING A PLUS.
- Ability to manage multiple tasks and be detail-oriented.
- RAC CERTIFICATION IS A STRONG PREFERENCE
APPLY NOW FOR IMMEDIATE INTERVIEWS !
One of my Clinical Clients is urgently looking for a Regulatory Affairs Specialist for a 6-12 month contract in Bern, Switzerland. assist in the creation of technical documentation (technical files and design dossiers) for the DePuy Synthes TCMFB 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 labelling.
- 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 OneMD technical documentation structure proposed by the MDR 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, Labelling, 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 SPEAKING REQUIRED, GERMAN SPEAKING A PLUS.
- Ability to manage multiple tasks and be detail-oriented.
- RAC CERTIFICATION IS A STRONG PREFERENCE
APPLY NOW FOR IMMEDIATE INTERVIEWS !
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Sonstiges