Regulatory Affairs Specialist

What you will be doing:

Ensure regulatory compliance of defined products and processes
Development and timely submission of regulatory applications, license renewals, periodic updates and registrations of defined products with different regulatory agencies
Provide regulatory inputs to various Insightec teams (e.g. R&D, Operations, Quality, Marketing) both locally and around the world, along all stages of product lifecycle (pre and post market), to ensure compliance with procedures and regulatory requirements
Actively participate in regulatory impact evaluation of changes to Insightec’s products and processes
Provide technical review of data/reports that will be incorporated into regulatory submissions, to assure scientific rigor, accuracy, and clarity
Provide support for external/internal audits at HQ and globally, as needed
Help develop internal Regulatory Affairs related processes and knowledge share databases
Review of customer complaints to determine regulatory reportability requirements and execution of global adverse events reporting; analyze adverse events reporting data and investigations, as required
Participate in research of arising regulatory issues
Attend other regulatory related needs, as required

What you have:

BSc. in Scientific / Engineering/ Paramedical/Public Health/Pharmacy
2+ years of global Regulatory Affairs experience, addressing pre/post market medical device regulatory requirements of the US FDA (Class III and/or Class II medical devices), EU notified bodies, Asian regulatory authorities, Israel MoH, etc.
Strong ability of text analysis and independent writing
Ability to assess and interpret regulatory requirements and their impact
Demonstrate sound scientific and technical knowledge
Ability to work with cross-functional global teams
Strong verbal and written communication skills (Hebrew and English)
Ability to multitask manage multiple projects to meet deadlines

Advantages:

Advanced degree
RAPS RAC
Being introduced by an Insightec employee

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Regulatory Affairs Specialist

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