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 INSIGHTEC’s 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.

What you have:

BSc. degree in scientific / technical discipline / engineering.
A minimum of 4 years of Regulatory Affairs experience with the US FDA and EU regulatory agencies (Class II and/or Class III medical devices)

Advantages:

RAPS RAC (Medical Device)
Advanced degree.

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Regulatory Affairs Specialist

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