Regulatory Affairs Specialist

Haifa        ·       Full time

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

Please click here to apply.