Regulatory Affairs Specialist (Replacement for a long maternity leave)
What you will be doing:
- Provide required regulatory support to all phases of INSIGHTEC’s products Design (Design and Development Planning, Design Input and Output, Design Review, Verification & Validation, Design Transfer and Design Changes), to ensure compliance with procedures and regulatory requirements
- Preparation and maintenance of regulatory submissions and licenses of INSIGHTEC products in relevant markets
- Preparation and maintenance of annual renewals of Establishment Registrations, Device Listing, and other pertinent regulatory licenses
- 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
- Actively participate in regulatory impact evaluation of changes to the INSIGHTEC’s QMS documents and device design/process, on pending or existing registrations
- 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
- Participate in post market related regulatory activities (e.g. PMS, CER, Adverse events reporting)
- Provide support for all external/internal audits at HQ and globally, as needed
- Help develop internal Regulatory Affairs related processes
- Provide ongoing regulatory support and assessments to different QMS related processes (e.g. MRB, CAPA, Contract review)
- 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
- Advise project teams on premarket regulatory requirements, labeling requirements and/or clinical study compliance issues
- Participate in compliance activities that relate to the department and the company
- Attend other regulatory related needs, as required
What you have:
- B.Sc. degree in Scientific / Technical discipline / Engineering/ Paramedical/Public health/Pharmacy. Advanced degree preferred.
- 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.
- Analytic thinking, 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)
- Good Excel and Word knowledge
- Ability to multitask manage multiple projects to meet deadlines
- Present positive attitude and team spirit
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