Regulatory Affairs Specialist
Insightec
Apply to this jobWhat 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.
Let us introduce ourselves
Insightec is a growing medical technology company transforming patient lives through innovative incisionless surgery. Based on two decades of clinical experience and research and development, the company’s Exablate® Neuro platform focuses sound waves, guided by MRI, to provide tremor relief to patients with Essential Tremor and Tremor-dominant Parkinson’s Disease.
Research for future applications in the neuroscience space is underway in partnership with leading academic and medical institutions.
We are a global team united by a common vision to transform healthcare by making focused ultrasound a standard of care for patients. Our culture is built on Our Values of integrity, team, quality, innovation and patient care. We challenge and empower our people to be great at what they do and leverage our different ideas, skills, interests and cultural backgrounds to succeed.
After a recent investment round, Insightec is valued at more than $1B, bringing it to unicorn status. We are over 350 strong in Haifa and K. Ono in Israel, Miami, Dallas, Shanghai and Tokyo.
Do the most meaningful work of your career by joining us in our mission to make the impossible possible.
Insightec is an equal opportunity employer and is committed to a safe work environment free from discrimination, where employees are treated with dignity and respect. Insightec does not discriminate against any employee or applicant on the basis of race, color, religion, national or ethnic origin, sexual orientation, gender identity or expression, age, disability or other characteristics protected by law. We adhere to these principles in all aspects of employment including hiring.
Summary
Provide regulatory support for product submissions and compliance activities.
Job title
Regulatory Affairs Specialist
Experience level
4+ years
Industry
medical technology
Location requirements
Located in Haifa, Israel; remote work not allowed.
Salary
Not specified
Management role
No
Required skills
Preferred skills
Specializations
Structured locations inferred from the posting.
Haifa, Israel