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The Regulatory Affairs Specialist provides regulatory guidance for business unit product lines. The Regulatory Affairs Specialist works directly with cross functional teams to support global product market clearances .

Your role:
Act as the Regulatory Affairs representative for CT/AMI products, supporting regulatory activities such as labeling, marketing, technical documentation, global registrations, and regulatory design change assessments within the product Development Life Cycle.
Provide regulatory guidance to cross-functional teams throughout all design control phases for new products and major/minor changes.
Coordinate and prepare document packages to support global submissions and regulatory activities.
Support regulatory audits and compliance activities.
Serve as the local regulatory liaison between markets and the BIU site.
Maintain Product Shipment Authorization for CT/AMI product lines, ensuring compliance with localization and licensing requirements

we are looking for a Regulatory Affairs Specialist
What you will be doing:

Provide regulatory support to the Development and Post marketing activities related to INSIGHTEC products.
Preparation and maintenance of regulatory submissions and registrations of INSIGHTEC products in relevant markets.
Review complex reports, validations, etc. for scientific merit and regulatory appropriateness; Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation
Preparation and maintenance of annual renewals of Establishment Registrations, Device Listing, and other pertinent regulatory licenses.
Review of customer complaints to determine reportability according to regulatory requirements and execution of reporting per determination.
Provide ongoing regulatory support and assessments to different QMS related processes (e.g. MRB, CAPA, Contract review)
Actively participate in the evaluation of changes to the INSIGHTECs QMS documents and device design/process for impact on pending or existing registrations
Provide support for all external/internal audits at HQ and globally, as needed
Advise project teams on premarket regulatory requirements, labeling requirements and/or other compliance issues.
Work closely with various other INSIGHTEC teams (e.g. R&D, Operations, Quality, Marketing) both locally and around the world, to provide regulatory inputs as needed.
Monitor and advise the organization of upcoming or new guidance, regulations, agency/industry initiatives, etc. to ensure ongoing regulatory compliance
Attend other regulatory related needs, as required
Working according to Insightec Quality Policy, relevant Quality Procedures & Standards, and privacy & safety rules.