Global Regulatory Affairs Manager – Medical Devices (Flexible Work)

Insightec; United States; 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

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.