Regulatory Affairs Specialist

Envista

Kloten, Switzerland

Job Description:
• Contribute to execution of distributed product development, change, compliance and lifecycle management activity projects/activities for market access to EU, US & CA to ensure all RA related strategies, elements & requirements implemented and collaborate with other Nobel RA teams for smooth registration in applicable markets.
• Create, review and maintain product technical files.
• Support provision of regulatory guidance for Nobel Biocare IFU and labeling.
• Contribution to review and approval of product related labeling and marketing material and associated claims.
• Support internal and external audits with audit preparation and in audit back office.
• Support the creation and maintenance of regulatory procedures and templates.
• Support monitoring of guidelines, regulations, changes in the marketplace and regulatory positions for the assigned markets including creation of gap analyses.
• Maintain UDI processes (such as GUDID) and contribute to implement... More Detail

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