What you will be doing
- Working according to Insightec Quality Policy, relevant Quality Procedures & Standards, and privacy & safety rules.
- Preparation and maintenance of regulatory submissions and registrations of INSIGHTEC devices to PMDA/ARCB.
- Preparation and maintenance of regulatory submissions and registrations of INSIGHTEC devices in APAC countries (e.g. Taiwan, Singapore, Korea, India, SEA), directly with authorities or via local agents.
- Development of annual Post Market Survey (PMS) reports to PMDA, and develop a submission document for re-evaluation on applicable INSIGHTEC devices based on data reports by CRO Information collection of an amendment of local premarket regulatory requirements.
- Interpretation of local regulator rules or rule changes and ensure that they are communicated through corporate policies and procedures
- Work closely with various teams of Country manager reporting lines (CRO, Applications, CAM, Marketing) located at the INSIGHTEC Japan office
- Perform other duties RA associated as required
What you have
- Meet the requirements on Safety Controller
- Apply business and Safety ethical standards
- Multitask and manage multiple projects to meet deadlines
- Work with cross-functional teams (located in JP)
- Communicate effectively in writing (English/JP) as well as with team members from various cultural backgrounds, verbal English communication is preferable.
- Ability to foster relationships with regulatory agencies, TMG consultants and colleagues
- Write, review, and prepare complex documents (English/JP)
- Think analytically and critically
- Proficient with Microsoft Office
- B.Sc. or B.A. degree in scientific or technical discipline. Advanced degree preferred.
- Experience to create STED
- Experience with Class II and Class III medical device in Japan and preferably also in Taiwan, Korea, ,
- Knowledge/experience with QMS/ISO13485 is preferable
Other Requirements:
- Ability to travel both domestically and internationally is required
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.
