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Regulatory Affairs Manager (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Support, Sap
Projektbeschreibung
REFERENZNUMMER:
304245/11
IHRE AUFGABEN:
-Development and execution of regulatory strategies for assigned projects on implant systems in major markets, i.e. EU, USA, CAN and AUS
-Accountable for regulatory compliance and support of product development in cross functional teams
-Creation, review and/or approval of documents of the design control process
-Support international product registration by advising the responsible Regulatory Affairs Manager in international projects
-Assessment, approval and regulatory implementation of change requests
-Review and approval of product related labelling and marketing material
-Support SAP-based reporting system
-Provide internal training with respect to relevant procedures and requirements
IHRE QUALIFIKATIONEN:
-Scientific or technical background, university degree is of advantage
-Profound experience in regulatory affairs within the medical device industry
-Good knowledge of medical device legislation EU, USA, CAN and AUS and corresponding guidelines
-Good knowledge of product development processes in the medical device industry
-Good knowledge of quality system requirements such as ISO 13485 and FDAs 21 CFR Part 820
-Experience in preparation of notified body audits and FDA inspections
-Experience with EU, US, AUS and CAN medical device regulations
-Fluency in English, further languages (especially German) are of advantage
-Strong interpersonal, writing and communication skills, ability to work in an international matrix organisation
WEITERE QUALIFIKATIONEN:
Regulatory affairs manager
304245/11
IHRE AUFGABEN:
-Development and execution of regulatory strategies for assigned projects on implant systems in major markets, i.e. EU, USA, CAN and AUS
-Accountable for regulatory compliance and support of product development in cross functional teams
-Creation, review and/or approval of documents of the design control process
-Support international product registration by advising the responsible Regulatory Affairs Manager in international projects
-Assessment, approval and regulatory implementation of change requests
-Review and approval of product related labelling and marketing material
-Support SAP-based reporting system
-Provide internal training with respect to relevant procedures and requirements
IHRE QUALIFIKATIONEN:
-Scientific or technical background, university degree is of advantage
-Profound experience in regulatory affairs within the medical device industry
-Good knowledge of medical device legislation EU, USA, CAN and AUS and corresponding guidelines
-Good knowledge of product development processes in the medical device industry
-Good knowledge of quality system requirements such as ISO 13485 and FDAs 21 CFR Part 820
-Experience in preparation of notified body audits and FDA inspections
-Experience with EU, US, AUS and CAN medical device regulations
-Fluency in English, further languages (especially German) are of advantage
-Strong interpersonal, writing and communication skills, ability to work in an international matrix organisation
WEITERE QUALIFIKATIONEN:
Regulatory affairs manager
Projektdetails
Geforderte Qualifikationen
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Kategorie:
SAP Entwicklung, Sonstiges