What are the responsibilities and job description for the Regulatory Affairs Manager position at INSIGHTEC?
Insightec is a growing medical technology company transforming patient lives through innovative incisionless surgery.
Our culture is as unique as our people, a diverse global team, with different ideas, skills, interests, and cultural backgrounds driven by our core values – Our Patients, Integrity, Team, Quality and Innovation.
Our dedication to making a real impact on the lives of millions of people and paving the path to a bright future for healthcare, is what bonds us as a Team. We work together in a dynamic collaborative environment to deliver successfully while believing and driving a life-work balance philosophy that encourages our employees to do things that are meaningful outside of work. Every role is significant, your voice is heard, and your ideas are encouraged. We challenge and empower our people to be great at what they do while providing a flexible work environment.
Walking through our corridors, you will be inspired by stories of career journeys at Insightec. We take pride in growing internal talent and encourage our employees to achieve their professional ambitions. With employees in Israel - Haifa and K. Ono, Miami and Dallas, Shanghai, Tokyo and Europe, we offer in each region competitive perks and benefits.
Do the most meaningful work of your career by joining us on our mission to transform tomorrows, today.
What you will be doing:
- Serve as US Agent for Insightec
- Provide regulatory support to the Clinical and Post marketing activities related to INSIGHTEC products.
- Preparation and maintenance of clinical regulatory submissions and registrations of INSIGHTEC products in relevant markets.
- Review clinical documents for regulatory appropriateness; Provide 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 Promotional materials
- 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, Clinical, 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, and other applicable standards 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.
Qualifications:
- B.Sc. degree in scientific / technical discipline / engineering.
- A minimum of 6 years of Regulatory Affairs experience with the US FDA and EU regulatory agencies
- Hands-on experience with Class III medical devices, including IDE/IND, ITA/CTA, EU CTAs, PMAs, 510(k)s, and CE Mark submissions
- Strong verbal and written communication skills
- Ability to work with cross-functional global teams