Regulatory Affairs Manager

INSIGHTEC Ltd.; Northern (KY); Hybrid; USD 110,000 - 160,000; Full time

Job summary

INSIGHTEC Ltd. is seeking a regulatory affairs professional to lead clinical submissions for our incisionless medical devices in US markets. You will review data, prepare submissions, and act as US Agent while coordinating with global teams to ensure regulatory compliance.

The role emphasizes cross-functional collaboration, maintaining up-to-date regulatory knowledge, and supporting audits and promotional materials with rigorous documentation.

Qualifications

• B.Sc. degree in scientific/technical discipline or engineering.
• Minimum 6 years of hands-on experience with medical device clinical submissions (IDE/IND, ITA/CTA, EU CTAs).
• Strong verbal and written communication skills.
• Ability to work with cross-functional global teams.

Responsibilities

• Prepare and maintain clinical regulatory submissions of INSIGHTEC products in relevant markets.
• Review clinical documents for regulatory appropriateness.
• Provide review of data or reports used in regulatory submissions to ensure scientific rigor and clarity.
• Serve as US Agent for Insightec.
• Manage cross-functional processes to support regulatory, clinical and post-marketing activities.
• Manage annual renewals of Establishment Registrations, Device Listings, and other licenses.
• Review customer complaints to determine reportability.
• Provide ongoing regulatory support for promotional materials.
• Keep knowledge of new standards, guidance, regulations and other applicable standards up to date.
• Support external/internal audits at HQ and globally.
• Collaborate with R&D, Clinical, Quality, Marketing teams locally and globally.

Skills

Project management

Cross-functional teamwork

Regulatory submissions

Regulatory knowledge

Strong communication

Education

B.Sc. in scientific/technical discipline/engineering

Job description

Insightecis 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:

• Preparation and maintenance of clinical regulatory submissions 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.
• Serve as US Agent for Insightec.
• Manage cross-functional processes to support Regulatory, Clinical and Post marketing activities related to INSIGHTEC products.
• Management of annual renewals of Establishment Registrations, Device Listing, and other pertinent regulatory licenses.
• Review of customer complaints to determine reportability according to regulatory requirements.
• Provide ongoing regulatory support and assessments to Promotional materials.
• Manage company’s knowledge of new standards, guidance, regulations and other applicable standards to ensure ongoing regulatory compliance.
• Provide support for all external/internal audits at HQ and globally.
• Work closely with various other INSIGHTEC teams (e.g. R&D, Clinical, Quality, Marketing) both locally and globally.
• Working according to Insightec quality policy, procedures & standards, and privacy & safety rules.

Qualifications:

• B.Sc. degree in scientific / technical discipline / engineering
• Project Management skills
• A minimum of 6 years of Hands-on experience with medical devices clinical submissions, including IDE/IND, ITA/CTA, EU CTAs
• Strong verbal and written communication skills
• Ability to work with cross-functional global teams

Advantages:

• Experience with Class III products
• Being introduced by an Insightec employee