Manager of Regulatory Affairs
What you will be doing:
- Preparation and maintenance of clinical regulatory submissions primarily in the US (FDA) and Canada (Health Canada), and globally as needed
- Preparation and submittal of periodic IDE reports for Insightec’s Class III devices in the US
- Preparation and maintenance of annual renewals of Establishment Registrations, Device Listing, and other pertinent regulatory licenses, as needed
- Actively participate in evaluation of changes to the Insightec’s QMS documents and device design/process to identify the appropriate regulatory pathways and IDE submissions
- Review complex reports, validations, etc. for scientific merit and regulatory appropriateness; Provide technical review of data or reports that will be incorporated into investigational regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation
- In collaboration with the VP global Regulated Clinical Affairs, advise project teams on IDE regulatory requirements, and/or clinical study compliance issues
- Monitor and advise the Clinical Affairs team of upcoming or new guidance, regulations, agency/industry initiatives, etc. to ensure regulatory strategies are in alignment with company objectives
- Interpretation of regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures
- Participate in compliance activities that relate to the department and the company, when needed
- Work closely with various teams (i.e. Regulatory Affairs, R&D, Quality, Manufacturing and Marketing) located at the Insightec’s headquarters in Israel and ROW
- Perform other duties as required
What you have:
- S. or B.A. degree in scientific or technical discipline. Advanced degree preferred.
- A minimum of 8 years of working in an FDA regulated environment,
- A minimum of 5 years of Clinical Regulatory Affairs experience in Class III and/or Class II medical device IDE/PMA supplements submission to the US FDA and Health Canada.
- Apply business and clinical RA ethical standards
- Regulatory experience with devices is required, including prior experience working on IDE, PMA, and 510K submissions in the US
- Regulatory experience in Canada, Europe, and / or major geographies highly desirable
- Demonstrated knowledge of regulatory requirements with the ability to interpret and apply regulations to specific projects (IDE, PMA, GCP, ICH and other regulatory guidance requirements)
- Regulatory experience with drugs regulations and IND submissions is desirable.
- Work with cross-functional teams (located in the US and Israel)
- Ability to travel both domestically and internationally is required
- RAPS RAC (US) preferred
- Being introduced by an Insightec employee
Successful candidate(s) will be required to comply with Insightec’s Vaccination Policy.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender/gender identity, age, disability, marital status, sexual orientation, national origin, veteran status, and any other legally protected status entitled to protection under federal, state, or local anti-discrimination laws.
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エクサブレート・ニューロ（Exablate Neuro）は販売名「MRガイド下集束超音波治療器 ExAblate 4000」のことです。